Accurate and compliant labeling is a cornerstone of medical device manufacturing, yet it remains one of the most complex and challenging aspects of the industry. With the regulatory landscape continuously evolving, manufacturers must navigate a labyrinth of global requirements while ensuring workflows are efficient and error-free.  

This article will guide you through the foundational requirements in the US and EU, explore common challenges, and share best practices to help you streamline your labeling processes and maintain compliance.

What is Medical Device Labeling?  

Medical devices encompass a wide range of products designed to diagnose, treat, or prevent medical conditions. If you’re unsure whether your product qualifies as a medical device, the FDA’s classification tool can help clarify.  

But what exactly constitutes a "label"? According to the FDA's definition, it includes all written, printed, or graphic materials associated with a medical device. This extends to Instructions for Use (IFUs), packaging, and any accompanying materials.

Key Regulatory Requirements for Medical Device Labeling  

Both US and EU regulations share a commitment to ensuring safety, efficacy, and transparency. However, the nuances between these frameworks require manufacturers to tailor their processes accordingly.  

US FDA Requirements  

The FDA’s labeling requirements focus on providing clear, accurate, and comprehensive information about the device’s use, safety, and risks. Labels must include details like:  
- Device name and intended use
- Directions for use
- Warnings and precautions

You can find a complete overview on the FDA's device labeling page. For further insights into FDA requirements, explore our guide to 21 CFR Part 211.

EU MDR Requirements  

The EU MDR emphasizes multilingual compliance, CE marking, and detailed Instructions for Use (IFU). Essential label elements include:  
- CE marking  
- Unique Device Identifier (UDI)  
- Appropriate symbols and pictograms for clarity  

For detailed EU MDR labeling requirements, refer to the official documentation. Learn more about how our software supports EU MDR compliance on our dedicated page.  

Common Challenges in Medical Device Labeling  

Keeping Up with Regulatory Changes
Frequent regulatory updates can turn compliance into an ongoing challenge. Each change might require updates to tens of thousands of labels, creating a significant headache for suppliers. To stay ahead, it's crucial to have software in place that can quickly and easily manage these mass label updates—keeping you ready for whatever changes come next.

Managing Multilingual Labels
For global suppliers, ensuring labels are understood by consumers across different regions is critical. Multilingual compliance, especially under EU MDR, requires precise and culturally relevant translations—adding another layer of complexity to the labeling process.

Complex Approval Processes
The approval workflows for Class II and III devices can involve multiple stakeholders, often leading to long delays. That's why it's essential to use an intuitive, end-to-end platform that streamlines the approval process and keeps everything running smoothly and efficiently.

Discover how Kallik’s medical device labeling software helps mitigate these challenges. Having been built with compliance in mind, our end-to-end Veraciti™ software makes all of the above easier than ever.

Best Practices for Ensuring Labeling Compliance  

Automate and Centralize Processes  
End-to-end software solutions streamline label creation and updates by automating key tasks, reducing manual errors, and ensuring consistent regulatory compliance. Centralizing your labeling processes in one platform allows you to quickly implement changes across multiple regions, ensuring your labels are always up to date with the latest requirements and eliminating time-consuming manual revisions.

Implement Robust Version Control  
A solid version control system keeps track of all label iterations, ensuring only the most current version is in circulation. This reduces the risk of distributing outdated labels and simplifies audits, as you can quickly access historical versions and verify compliance. It also fosters collaboration by providing clear visibility into changes and approvals, keeping your labeling process secure and efficient.

Digital Proofing and Approval Workflows  
Automated proofing and approval workflows speed up the approval process by ensuring labels are reviewed and signed off quickly and accurately. With digital tools, you can spot errors early, streamline collaboration, and reduce delays, ensuring that labels meet regulatory and internal standards efficiently, without the bottlenecks typical of manual approval processes.

Learn more about how Veraciti's automated tools can help with your medical device labeling on our label management page.  

Leveraging Labeling Software for Compliance  

Kallik delivers speed to market, compliance and change management for complex product labeling and artwork portfolios that significantly challenge medical device organizations.  Whether driven by localized market requirements, merger and acquisition or the launch of a new product, our software can ensure that your organization completes artwork and labeling projects with unrivalled speed and compliance. 

With fully customizable role-based digital approval flows, label automation, advanced reporting, and full audit logs, you can ensure total regulatory confidence in your medical device product labeling and artwork. 

One example is our partnership with Ossur, where our solution enabled seamless global labeling compliance. By centralizing and standardizing IFU data, Össur gained complete visibility and streamlined the creation and approval of Instructions for Use (IFUs) across hundreds of products. This transformation reduced cycle times, cut translation costs, and ensured compliance while simplifying future regulatory updates. Veraciti’s automation and phrase reusability not only improved operational efficiency but also enhanced the customer experience by delivering clearer, standardized product information. Read the full case study here. 

Kallik has extensive experience partnering with medical device organizations and manufacturers. Our label and artwork management solution, Veraciti, is constantly evolving to meet the dynamic needs of the medical device industry. Contact us today at enquiries@kallik.com to discover how Kallik can streamline your labeling and artwork management process. Book a demo to see how Kallik can transform your labeling process.

As businesses look ahead to 2025, one of the most significant trends reshaping the labeling and artwork industry is the rise of electronic Instructions for Use (eIFUs). With increasing regulatory demands, technological advancements, and a growing emphasis on sustainability, eIFUs are fast becoming a key solution for companies aiming to streamline their processes, improve customer experience, and reduce their environmental impact.

What Are IFUs and eIFUs?

In the healthcare and medical device industries, Instruction for Use (IFU) documents play a critical role in ensuring the safe and effective use of products. Traditional IFUs are physical paper-based manuals or leaflets that accompany medical devices, providing essential information on their operation, maintenance, and safety precautions.

You might see one with a medical device like a glucose meter. The IFU would typically be a printed booklet or leaflet included in the packaging. It would provide essential information such as setup instructions, how to use the device properly, maintenance tips, troubleshooting guidance, and safety precautions. The IFU might also include diagrams or images to illustrate the steps clearly, ensuring users can effectively operate the device and understand its features.

However, with the rapid digitization of information, electronic Instructions for Use (eIFUs) are emerging as a modern alternative. eIFUs are digital versions of these instructional documents that can be accessed online or through electronic devices, offering advantages such as easier updates, reduced environmental impact, and enhanced accessibility for users worldwide.

An eIFU can take various forms, such as a downloadable PDF, an interactive web-based guide, or a mobile application which might be accessed by scanning a QR code on the product packaging or an NFC tag embedded in the product itself. These formats offer users easy access to comprehensive product information, ensuring they can efficiently utilize the product. For example, a medical device manufacturer might use an eIFU for a complex surgical instrument. Surgeons can access the eIFU via a secure app on their tablets, where they find step-by-step instructions, video demonstrations, and troubleshooting tips. This digital format allows healthcare professionals to familiarize themselves with the device before procedures, enhancing safety and efficacy in clinical settings.

How Do eIFUs Work?

eIFUs are designed to be easily accessible to end-users, whether they’re professionals in healthcare settings or general consumers. Here’s how they typically work:

Digital Hosting: Companies host eIFUs on secure, compliant platforms—often accessible via a simple website or through a mobile app.

Access Points: End-users can easily access the information by scanning a QR code, visiting a URL, or tapping an NFC-enabled device.

Version Control: Unlike printed documents that may become outdated, eIFUs can be updated in real-time, ensuring users always have the latest information without needing to reprint and redistribute materials.

Multilingual Options: eIFUs allow companies to provide multiple language options seamlessly, often reducing the complexity and cost associated with printing different versions for different markets.

The Benefits of eIFUs

The switch to eIFUs is not just about staying ahead of the technology curve—there are tangible benefits that can directly impact a company’s bottom line and sustainability initiatives.

Cost Efficiency: Printing, shipping, and storing physical IFUs are expensive processes. By going digital, businesses significantly reduce these costs, freeing up resources for other areas of development.

Enhanced User Experience: eIFUs offer a superior user experience, as they are always accessible and easy to navigate. With built-in search functions, users can quickly find the specific information they need, saving time and improving product usability.

Regulatory Compliance: Many industries, particularly healthcare, have stringent requirements for product labeling. eIFUs allow companies to ensure compliance with these regulations by providing real-time updates and version control, minimizing the risk of distributing outdated or non-compliant instructions.

Customization and Personalization: eIFUs can be tailored to individual users’ needs, offering additional information or guidance based on specific use cases. This level of customization is difficult to achieve with printed materials but is easily manageable in a digital format.

eIFUs: A Powerful Tool for Sustainability

Sustainability is no longer just a buzzword—it’s a core business priority. Companies across industries are striving to meet ambitious sustainability goals, and eIFUs are playing a key role in this effort.

Reduced Paper Waste: Traditional IFUs often run multiple pages and are included with every product, generating significant amounts of paper waste. Switching to digital formats cuts down on this waste, aligning with broader corporate sustainability goals.

Lower Carbon Footprint: By eliminating the need for printing and shipping physical documents, companies reduce their carbon emissions. The process of producing and distributing printed materials requires substantial energy and resources, from paper production to transportation.

Minimized Resource Use: eIFUs require fewer resources overall, from raw materials (like paper and ink) to the energy used in the printing process. This resource minimization is crucial as businesses aim to reduce their environmental impact and move toward more circular, sustainable practices.

Why eIFUs Will Dominate in 2025

As we move toward 2025, eIFUs are poised to become one of the biggest trends in labeling and artwork management. The combination of regulatory demand, technological ease, and a global shift toward sustainability means more companies will be adopting this digital-first approach to product labeling. The healthcare and pharmaceutical sectors are already leading the charge, but industries ranging from consumer electronics to cosmetics are quickly recognizing the advantages.

Moreover, the increasing adoption of cloud-based systems, AI, and automation in labeling and artwork management will make the creation, distribution, and management of eIFUs even more efficient. Solutions like Veraciti, with its AI-powered automation tools, are making it easier than ever to integrate eIFUs into existing systems, ensuring businesses can stay ahead of the curve while also meeting sustainability objectives.

Get Ahead of the Curve

eIFUs are not just a fleeting trend; they represent a fundamental shift in how businesses approach product labeling. With their cost-saving, user-friendly, and sustainable benefits, eIFUs are set to redefine the labeling and artwork landscape in 2025 and beyond. Companies that embrace this transition will not only be meeting regulatory requirements and enhancing customer experience—they’ll also be playing their part in building a more sustainable future.

Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

With tomorrow being Halloween, it's the perfect time to talk about some real-life labeling and artwork "horror stories" that have left companies facing consumer nightmares and costly recalls. But don’t worry—there’s no need to scream in terror! We’ll also explore how you can avoid these frightful errors by implementing end-to-end, cloud-based, automated solutions to keep your processes smooth and compliant.

Here are five real-life cautionary tales of companies who fell victim to labeling errors—and how they could have been avoided with the right technology:

1. Pharmaceutical Dosage Disaster

In 2003, Pfizer faced a major issue with the hormone replacement therapy drug Prempro due to labeling problems that resulted in miscommunication about dosage and instructions. This labeling failure led to confusion among patients and healthcare providers, contributing to adverse health effects and subsequent legal actions. The incident eventually culminated in a large settlement, as Pfizer was accused of providing unclear or incorrect dosage details that heightened health risks for users, and the legal repercussions continued over the years as additional safety concerns related to the drug surfaced.

The legal battles Pfizer faced regarding Prempro included a larger settlement in 2011, amounting to over $330 million, when they resolved around 2,200 cases that alleged links between Prempro and increased risks of breast cancer. This case emphasized the serious consequences of inadequate labeling in the pharmaceutical industry, where even minor inaccuracies can lead to significant patient health risks and liability concerns for companies.

2. Leading Supermarket’s Allergen Labeling Fail

The 2015 Tesco allergen labeling incident involved a mislabeled batch of crisps that posed a serious risk to consumers with dairy allergies. A package of cheese and onion crisps was incorrectly labeled as salt and vinegar, omitting the presence of milk allergens. The oversight, part of Tesco's "Free From" range that caters to people with food allergies and dietary restrictions, exposed customers to potential allergic reactions, prompting the company to issue a recall and eventually resulting in a £300,000 fine from the Westminster Magistrates’ Court. The court emphasized the gravity of the incident, highlighting the responsibility of major retailers to ensure rigorous allergen labeling to protect consumers' health.

3. Cereal Manufacturer’s Peanut Residue Recall

In 2016, Kellogg’s recalled about 10,000 cases of its Keebler and Famous Amos cookies due to undeclared peanut residue. This oversight, traced to a flour supplier, posed serious risks to consumers with peanut allergies, who could suffer severe reactions from exposure. The affected products included several types of cookies, such as Keebler’s Animals Crackers and Famous Amos Double Chocolate Chip cookies. This widespread recall emphasized the importance of thorough allergen checks and clear labeling in the food industry. Although no illnesses were reported, the incident served as a strong reminder of the critical role accurate labeling plays in protecting consumer health​.

4. Frozen Meals Mislabeling

In 2017, Conagra Foods issued a significant recall on its Healthy Choice Power Bowls due to a dangerous labeling error. The meals, labeled as Korean-Style Beef, actually contained a chicken sausage and pepper product that included milk—an allergen not declared on the packaging. This posed a serious risk for those with dairy allergies, prompting the USDA to classify it as a Class I recall, indicating the potential for serious health consequences. Fortunately, no adverse reactions were reported before the recall went public​.

5. Packaging Pains at Leading Consumer Healthcare Manufacturer

In 2008, a leading consumer healthcare manufacturer recalled approximately 5 million bottles of its painkiller tablets. The recall was initiated after it was discovered that the labels failed to specify the presence of certain allergens, which could pose risks to individuals with allergies. The labeling error was significant enough to warrant a recall to prevent potential adverse health effects.

Labeling Nightmares Like These Can be a Thing of the Past with End-to-End Cloud-Based Solutions

Labeling mistakes like these happen when teams rely on disconnected, siloed processes or outdated manual checks. But it doesn’t have to be this way! AI and automation play a key role in preventing human error by flagging discrepancies and automatically checking regulatory compliance. Meanwhile, cloud-based platforms mean better collaboration—no more passing around versions via email and risking outdated or incorrect artwork slipping through the cracks. Ultimately though, it’s all about using an end-to-end solution, eliminating siloes and communication issues between stakeholders. By managing the entire process in one single solution, you are greatly reducing the risk of errors in your labeling and artwork, something which could not only save a lot of money, but also potentially save lives.

Key Benefits of End-to-End Cloud-Based Software:

AI-Backed Automation: Automated checks and regulatory compliance built into the process prevent costly human errors.

No Silos: A centralized platform allows all teams, from regulatory to marketing, to collaborate in real-time, ensuring the correct version of labels and artwork is used.

Version Control: Every update is tracked, and no outdated versions are used.

Real-Time Collaboration: Cloud-based systems allow teams across different locations and time zones to work together seamlessly.

Kallik’s Veraciti: Your Savior from Labeling Nightmares

At Kallik, our Veraciti platform does all this and more. Built specifically for labeling and artwork management, Veraciti ensures regulatory compliance, streamlines processes, and prevents costly errors. With AI-backed tools and end-to-end cloud-based workflows, Veraciti keeps your teams in sync, your artwork flawless, and your labels always accurate.

This Halloween, don’t let your labeling process turn into a horror story—equip your team with the tools they need to succeed. Get in touch today to see what we can do for you at enquiries@kallik.com or call +44 (0) 1827 318100. Alternatively, click here to book a demo and discover how a cloud-based, end-to-end solution can simplify your process, ensuring accuracy, compliance, and efficiency from start to finish.

Traceability is more than just a buzzword in the medical device industry—it's a vital component of regulatory compliance, operational efficiency, and ultimately, patient safety. At Kallik, we understand the critical role that robust traceability plays in ensuring patient safety, meeting regulatory requirements, and enhancing supply chain transparency. This blog explores the importance of traceability, the role of emerging technologies in enhancing it, and how advanced solutions like Kallik’s Veraciti™ are setting new standards in the industry.

The Crucial Role of Traceability in Medical Devices

Traceability in the medical device sector involves tracking every stage of a product's lifecycle—from development and manufacturing to distribution and usage. This meticulous tracking ensures that each device can be accurately identified and traced back through its supply chain, which is essential for several reasons:

Patient Safety: Traceability helps in promptly identifying and recalling faulty devices, thereby protecting patients from potential harm.

Regulatory Compliance: Regulatory bodies, such as the FDA in the U.S. and the European Medicines Agency (EMA) in Europe, require stringent traceability standards to ensure that all medical devices meet safety and efficacy requirements.

Supply Chain Efficiency: Effective traceability can streamline the supply chain, reducing errors and improving coordination among stakeholders.

The European Union’s Unique Device Identifier (UDI) system, mandated in 2020 for medical devices and 2022 for in vitro diagnostic devices, highlights the growing importance of traceability. Despite delays in the implementation of the EUDAMED database, the push towards comprehensive traceability remains strong, underscoring its significance in the industry.

The Role of Digitalization in Enhancing Traceability
 

Digitalization is transforming traceability in the medical device industry by breaking down traditional silos and creating a more integrated, transparent supply chain. By digitalizing various stages of the supply chain, manufacturers can achieve significant improvements in efficiency and visibility.

Cultivating Consistency

Life sciences supply chains are highly complex, involving multiple tiers of suppliers and wholesalers. Digitalization helps cultivate consistency across these complex networks. A key element in supply chain optimization is having a single source of content that is consistent throughout the ecosystem. This "single source of truth" can be a statement, symbol, image, or a combination, approved as the definitive version. With digitalization, this master source can be seamlessly integrated into every stage, from product development to customer fulfillment, ensuring everyone is using the latest, accurate content.

Ensuring Interoperability

For global traceability, digitalization ensures that labeling content meets local regulatory requirements and broader regional mandates. This includes accommodating local safety statements, symbols, and translations. A centralized digital system can trace all labels back to the original master source, maintaining integrity and clarity for local readers. This global interoperability is crucial for end-to-end traceability, giving organizations complete visibility of label content across all markets.

Addressing Organizational Challenges

Implementing a harmonized system for positive identification of medical devices is more of an organizational challenge than a technical one. Digitalization can overcome these challenges by establishing clear data governance and ownership. It ensures that the right stakeholders are responsible for decisions about changes and updates to labeling, critical for meeting local market requirements and maintaining compliance.

Enhancing Decision-Making and Collaboration

Digitalization also improves decision-making and collaboration within the supply chain. By integrating systems and data, stakeholders can operate more seamlessly and collaboratively. Regulatory, marketing, and manufacturing teams, as well as third-party partners, can access the same system overseeing the master content, allowing for efficient updates, modifications, and reviews. This enhanced collaboration ensures that everyone is working with the most up-to-date and accurate information.

Strengthening Supply Chain Infrastructure

Visibility across the supply chain is essential for effective traceability. Digitalization ensures that an authoritative master copy of the content for each label is easily identifiable and accessible throughout the process. This prevents the use of outdated symbols or statements and ensures compliance with traceability requirements. It provides real-time visibility of the most recently approved content and details of who approved it and when.

Overcoming Digitalization Challenges

Transitioning to a digitalized labeling management system can be challenging, especially when existing content is in non-editable formats like PDFs, printed documents, or emails. However, digitalization involves making content available at an atomic level, breaking it down into specific elements such as phrases, statements, or symbols. These elements can then be reconstructed and reused to create accurate new labeling, ensuring consistency and compliance.

How Veraciti™ Sets New Standards in Traceability

While many companies are leveraging emerging technologies to improve traceability, Veraciti™ stands out for its comprehensive and innovative approach. Veraciti™ offers a unique set of features that differentiate it from competitors, providing the best possible traceability solutions for the medical device industry.

1. Centralized Content Management

Veraciti’s centralized content management system ensures that all labeling and packaging content is consistent and up-to-date across the entire supply chain. This centralization eliminates silos, ensuring that every stakeholder has access to the latest, approved content, thereby reducing errors and improving compliance.

2. Global Interoperability

Veraciti™ is designed to meet local regulatory requirements while maintaining global interoperability. The platform supports multiple languages and regional mandates, ensuring that labeling content is accurate and compliant worldwide. This global approach ensures that every device can be traced back to a single source of truth, providing complete visibility and traceability.

3. Enhanced Collaboration

Veraciti™ facilitates seamless collaboration among all stakeholders, including regulatory, marketing, and manufacturing teams. By providing a single platform for managing content, Veraciti ensures that all parties can update, review, and approve content efficiently. This collaborative approach extends to third-party partners, ensuring an integrated and transparent supply chain.

4. Real-Time Visibility

Veraciti™ offers real-time visibility into the supply chain, ensuring that all activities are transparent and traceable. This visibility is crucial for maintaining compliance and quickly responding to potential issues. By providing detailed insights into the entire supply chain, Veraciti™ helps companies maintain high standards of traceability.

5. Future-Proof Solutions

Veraciti™ is designed with the future in mind, supporting the ongoing digital transformation of the medical device industry. The platform’s robust architecture and advanced features ensure that it can adapt to evolving regulatory requirements and technological advancements, providing a future-proof solution for traceability.
 

Leading the Way For Maximum Traceability

In an industry where traceability is paramount, digitalization is reshaping how companies track and manage their products. By breaking down silos and creating a more integrated supply chain, digitalization enhances consistency, interoperability, and collaboration. 

Veraciti™ is leading the way in the industry by leveraging these advancements to offer a comprehensive, future-proof solution that sets new standards in the medical device industry. By focusing on centralized content management, global interoperability, enhanced collaboration, and real-time visibility, Veraciti™ ensures that companies can achieve the highest levels of traceability and regulatory compliance.

Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

With regulations changing and tightening constantly and consumer demands shifting with a heightened focus on sustainability, it's no wonder that artificial intelligence (AI) and automation are taking the labeling and artwork world by storm. 

The digital transformation in labeling and artwork management is well underway and throughout 2024 so far we've seen a huge focus on innovation in AI and automation. Let's look at the benefits of AI and automation in artwork and labeling software and the risks of being left behind if organizations fail to digitize their processes.
 

The AI Revolution in Labeling and Artwork Management

Artificial Intelligence (AI) is no longer a futuristic concept; it’s a reality that is transforming the way businesses manage their labeling and artwork processes. AI’s capabilities in data analysis, predictive maintenance, and process optimization are proving to be game-changers.

How AI is Affecting the Industry:

Data Accuracy and Consistency:
AI algorithms can analyze vast amounts of data with unprecedented accuracy. This ensures that labels and artwork are consistent across all products and regions, reducing the risk of errors and non-compliance.

Predictive Analytics:
AI-powered predictive analytics can forecast market trends and regulatory changes, enabling companies to stay ahead of the curve. This foresight helps in proactive label and artwork management, ensuring timely updates and compliance.

Personalization:
AI allows for the creation of highly personalized labels and artwork tailored to specific consumer segments. This targeted approach can enhance customer engagement and brand loyalty.

The Automation Advantage

Automation is another key trend that is streamlining the labeling and artwork management process. By automating repetitive and time-consuming tasks, companies can achieve greater efficiency and accuracy.

How Automation is Affecting the Industry:

Workflow Optimization:
Automation tools streamline the workflow from design to approval, reducing the time required to bring new products to market. Automated processes eliminate bottlenecks and ensure smooth transitions between stages.

Cost Efficiency:
By reducing manual labor and minimizing errors, automation significantly cuts operational costs. Companies can reallocate resources to more strategic tasks, driving innovation and growth.

Regulatory Compliance:
Automated systems can be programmed to adhere to the latest regulatory standards, ensuring that all labels and artwork comply with industry regulations. This reduces the risk of costly compliance issues and product recalls.

The Risks of Not Adopting AI and Automation

The risks of not keeping up with AI and automation are substantial and could see your business left behind very quickly. During Kallik’s recent webinar, held in partnership with the Regulatory Affairs Professionals Society (RAPS), Gartner's John Blake discussed the importance of composability brought about by this digital transformation, likening it to the evolution of the compact disc. “I would have to go find the music I want to put on a CD, I’d have to find a blank CD and I’d have to find a CD burner. I’d then have to mail a physical copy out too. So quite honestly, that would probably take about two weeks to do. But with the introduction of streaming services, which is also digital music, it's composable. I could give you the name of a song or an artist, I wouldn't even have to spell it correctly, and you could find it and be listening to it in seconds,” John highlights the power of digitalization.

He went on to summarize, “We need to think about this in our business processes. We need to think about how we manage and utilize technology to really improve our processes around artwork and labeling. And certainly, that has benefits in the regulatory space.” The benefits in terms of regulatory compliance and efficiency are profound and should not be overlooked. Companies that fail to embrace these technologies may face:

Increased Errors and Non-Compliance:
Without AI and automation, manual processes are prone to errors, leading to non-compliance with regulatory standards. This can result in significant financial penalties and damage to brand reputation.

Higher Operational Costs:
Manual labeling and artwork management are labor-intensive and costly. Companies that do not automate these processes will find it challenging to remain competitive in terms of pricing and efficiency.

Slower Time-to-Market:
In a fast-paced market, speed is crucial. Companies relying on outdated manual processes will struggle to keep up with competitors who have streamlined their operations with AI and automation.
 

Why Choose Kallik:
 

Compliance Assurance:
Our AI-driven solutions ensure that your labels and artwork are always compliant with the latest regulatory standards, minimizing risk and ensuring peace of mind.

Cost and Time Efficiency:
By automating workflows and utilizing AI, we help our clients achieve significant cost savings and faster time-to-market, providing a competitive edge in a crowded market. Speak to one of our experts about our AToM (Assisted Technology of Migration) technology, developed in partnership with Aston University and driven by AI to significantly streamline and simplify the migration process.

Expert Support:
Our team of experts is dedicated to helping you navigate the complexities of labeling and artwork management. We offer personalized support to ensure you get the most out of our innovative solutions.

Want to know more?

The labeling and artwork management industry is undergoing a transformative shift, driven by AI and automation. Companies that embrace these technologies stand to gain significant advantages in terms of compliance, cost efficiency, and speed. At Kallik, we are proud to lead the way in this technological revolution, providing our clients with the tools they need to stay ahead of the competition. Don’t risk falling behind—partner with Kallik and embrace the future of labeling and artwork management today. Speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business thrive in a rapidly changing regulatory environment. Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

When it comes to pharmaceuticals and medical devices, regulatory compliance stands as a cornerstone of patient safety and well-being. Yet, ensuring compliance with evolving standards and regulations poses significant challenges for organizations worldwide. Traditional methods of producing Instructions For Use (IFUs) and Patient Information Leaflets (PILs) have often proven inadequate in meeting these demands.

These documents serve as crucial sources of information for patients, providing guidance on the proper use of medical devices and medications. Inaccuracies or errors in these leaflets can have severe consequences. When it comes to pharmaceutical and medical device labeling, the risks can even be life-threatening.

Therefore, ensuring the accuracy and compliance of patient information and instructions for use leaflets is essential for safeguarding patient health and maintaining regulatory adherence. However, with the introduction of automation in the labeling and artwork industry, a new era of efficiency, compliance, and accuracy has arrived in IFU production.

Addressing Regulatory Gaps

As Bob Tilling, our label and artwork expert, highlights, regulatory compliance is crucial. Mid-sized device manufacturers often have to manage between 100 and 1,000 IFUs. Updating these documents to comply with the new EU Medical Device Regulation (EU MDR), which is significantly longer and more detailed than the previous directive, is a massive task.

Non-compliance with EU MDR labeling requirements not only puts patients at risk but also exposes organizations to legal repercussions and reputational damage. Traditional systems, including Product Lifecycle Management (PLM) systems, often fall short in controlling layout and content. Veraciti emerges as a beacon of hope, offering a comprehensive solution that not only manages content but also controls layout, ensuring compliance with regulatory standards.

Streamlining Processes, Eliminating Errors

The traditional approach to IFU production involves input from several stakeholders across the globe, consuming time and increasing the risk of errors. Veraciti revolutionizes this process by automating the generation of leaflets from a pre-approved single source of truth with automatic translations available, eliminating the need for manual intervention when creating and updating the leaflets.

Breaking Language Barriers, Ensuring Consistency

For IFU leaflets, it's crucial that the information can be correctly understood by patients and healthcare professionals worldwide. Veraciti enables organizations to swiftly generate IFUs in multiple languages within seconds. Unlike competitors who rely on less accurate methods like Google Translate, Veraciti offers pre-approved translations derived from a single source of truth, ensuring consistency and accuracy across all IFUs. This capability is a game-changer, empowering non-native speakers to access vital medical information with ease and confidence, ultimately contributing to improved healthcare outcomes globally.

Making the Move to eIFUs (Electronic IFU)

The transition from traditional paper-based IFUs to electronic formats marks a significant leap forward in efficiency and accessibility. Electronic IFU leaflets offer streamlined access, enhanced user experience, the ability to deliver multilingual content seamlessly, and significant sustainability benefits. With electronic IFUs, the process of updating information is far less time-consuming and involves less waste.

As Peter Muller explains in Med-Tech Intelligence, "Paper-based IFUs/PILs are printed in bulk, leading to waste when product/manufacturing information or safety advice needs to be updated. There may also be a level of risk to patients if they are accessing information that has been superseded."

Veraciti empowers organizations to generate IFUs in electronic formats, including XML files, ensuring compliance with regulatory standards while enhancing accessibility and integration. This capability enables organizations to navigate regulatory complexities with ease while delivering an unparalleled user experience.

Case Studies: Empowering Össur and Cardinal Health

Our collaboration with Össur, a leading provider of Class II medical devices, exemplifies the transformative impact of automation in IFU production. Össur faced numerous challenges, including disparate legacy systems, delays in product launches, and limited control over IFU assets. With Veraciti, Össur consolidated IFU phrases into a centralized system, enhanced visibility, and streamlined the approval process, ensuring compliance with regulatory requirements.

Similarly, our partnership with Cardinal Health, a global leader in healthcare services, highlights the critical importance of accuracy and compliance in IFU production. By streamlining the compliance process and eliminating errors, we have helped Cardinal Health navigate the complexities of regulatory standards, particularly in the context of MDR compliance.

Safeguarding Lives, Ensuring Compliance

By adopting our approach, the creation of multiple language EU MDR compliant 30-page IFUs has been reduced from 3-5 hours to just 30-40 minutes, with the time taken to generate individual labels reducing from 1 hour to around 10 minutes. For Class III devices alone, this efficiency has recovered 5 person-years of lost time.

In conclusion, automation in IFU production is a game-changer for compliance, accuracy, and efficiency. By leveraging the power of technology, organizations can streamline processes, eliminate errors, and ensure compliance with regulatory standards. Our partnerships with Össur and Cardinal Health underscore our commitment to empowering organizations with complete regulatory confidence.

For more information on the latest EU MDR and the issues with IFUs, read our blog: "EU MDR Labeling Compliance - Are We There Yet?" Looking for more advice? Speak to one of our experts by emailing enquiries@kallik.com.
 

With digital labeling and artwork management taking the world by storm, the concept of connected packaging is reshaping how consumers create products and how industries manage and deliver their goods. But what exactly is connected packaging, and how is it making such a positive impact?

So What is Connected Packaging?

Connected packaging refers to the integration of digital technology into product packaging, allowing consumers to interact with the packaging using their smartphones or other devices. Technologies like QR codes and NFC (Near Field Communication) tags enable this interaction, providing access to a wealth of information and services with a simple tap or scan.

Which Industries Are Benefiting the Most?

While connected packaging is making waves across various sectors, some industries are experiencing particularly transformative benefits:

- Pharmaceuticals and Medical Devices: Ensuring medication authenticity and offering dosage instructions.
- Fashion and Retail: Enhancing shopping experiences with virtual try-ons and style tips.
- Consumer Electronics: Offering installation guides and troubleshooting support.
- Food and Beverage: Providing detailed nutritional information and freshness tracking.

The days of cramming information onto your packaging are over!

By scanning a QR code or tapping an NFC tag, consumers can instantly access detailed product descriptions in any language they need, meaning there are no longer language barriers when it comes to marketing products and no need to modify labels and artwork for each country. Whether it’s a medical device needing instructions for use or a food or beverage item needing an ingredients list, a QR code can provide five or fifty language variations without affecting the label or artwork. Not to mention the opportunities for traceability so that consumers can understand where their products have come from and how they were made - vital in this day and age with people valuing transparency more than ever.

This brings us on to the topic of sustainability and understanding where and how packaging was made and what materials were used. Sustainability and environmental consciousness are increasingly important to consumers and manufacturers alike. Connected packaging is playing a vital role in promoting proper recycling practices by providing consumers with detailed, easy-to-access information. Here’s how connected packaging is making a difference:

Clear Recycling Instructions:

Material Identification: Connected packaging can help consumers identify the different materials used in the product and its packaging. For example, a product might have components made of plastic, glass, or metal, each requiring different recycling methods.

Step-by-Step Guides: Scanning a QR code or tapping an NFC tag can lead to step-by-step guides on how to recycle each component. This might include instructions on how to separate parts, clean them if necessary, and where to dispose of them.

Localized Recycling Information:

Custom Recycling Guidelines: Different regions have different recycling rules and facilities. Connected packaging can provide localized recycling information based on the consumer's location, ensuring that the instructions are relevant and accurate.

Recycling Centers and Drop-off Points: Consumers can be directed to nearby recycling centers or drop-off points, making it easier for them to recycle correctly.

Educational Content:

Environmental Impact Education: Brands can use connected packaging to educate consumers about the environmental impact of recycling and the benefits of proper disposal. This can include data on how much energy is saved by recycling, how recycling reduces landfill waste, and how it conserves natural resources.

Interactive Content: Interactive elements such as videos, animations, or quizzes can make learning about recycling more engaging and memorable for consumers.

Encouraging Responsible Disposal:

Incentives and Rewards: Some brands use connected packaging to offer incentives for recycling, such as discounts on future purchases, loyalty points, or donations to environmental causes. By rewarding responsible behavior, brands can motivate consumers to recycle more consistently.

Social Sharing: Consumers can be encouraged to share their recycling efforts on social media, using hashtags or participating in brand-led campaigns. This not only promotes recycling but also builds a community of environmentally conscious consumers.

Tracking and Reporting:

Recycling Data Collection: Brands can collect data on how often consumers access recycling information and how they engage with it. This data can help companies understand the effectiveness of their recycling initiatives and make improvements.

Transparency Reports: By providing transparency reports through connected packaging, brands can show consumers the real impact of their recycling efforts, such as the amount of material recycled or the reduction in carbon footprint.

Example Scenario

A consumer buys a bottle of water with a QR code on the label. By scanning the code with their smartphone, they access detailed instructions on how to recycle the bottle. The instructions include steps to rinse the bottle, remove the cap, and place the bottle and cap in different recycling bins.

The consumer is directed to a nearby recycling center and given the option to join a rewards program that offers discounts for every bottle recycled. The brand provides educational content on the importance of recycling plastic and how it helps reduce environmental pollution. The consumer can track their recycling efforts and see the positive impact they are making through the brand's transparency report.

Get Ahead of the Connected Packaging Revolution

The connected packaging revolution is transforming industries by making product information more accessible, improving supply chain transparency, and promoting sustainable practices. By integrating digital technology into packaging, brands can create richer, more engaging experiences for consumers while addressing critical issues like authenticity, transparency, and environmental impact. As this technology continues to evolve, we can expect even more innovative applications that will further enhance the way we interact with products and brands.

Kallik’s cloud-based, end-to-end innovative labeling and artwork platform, Veraciti™, is well equipped to help customers implement connected packaging, ensuring seamless integration of digital technologies and enhancing overall brand engagement and compliance. Our software can be used to generate and print QR codes with ease, enabling organizations to get ahead and take advantage of the connected packaging revolution.

Want to Know More?

Why not speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business to transform its product packaging process with the very best labeling and artwork management? Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.

Product recalls can be a nightmare for any company, and unfortunately, they’re more common than you might think with labeling errors a major cause for recalls. According to Packaging Digest, packaged product recalls increased by 63% in 2022.

In the pharmaceutical sector, according to Schlafender Hase, common labeling errors include incorrect dosage information, missing critical warnings, and incorrect storage instructions. For instance, mistakes such as "1-2 times a day" being printed as "12 times a day" or critical dosage information missing can lead to Class 1 recalls, where there is an immediate risk of death or serious injury.

Additionally, labeling issues often arise from manual proofreading errors and the complexities involved in updating labels to meet changing regulatory requirements across different regions. Errors in packaging content are among the most frequent culprits of recalls and where there is human input, human error is always to be expected.

Without a clear process for managing packaging content and the power of automation, companies put themselves and their consumers at significant business and personal risk. This is an area where paying attention to every detail is crucial in order to keep consumers safe.

Are you confident that your packaging management process can prevent recalls and keep your products safe for consumption? Let's explore how digital solutions can streamline your packaging content management process, safeguarding your brand, products, and most importantly, your consumers.

How Digital, Cloud-Based Labeling and Artwork Software Can Prevent Product Recalls

Content encompasses every element on a label or package containing a consumer product. Content management involves creating, modifying, organizing, and delivering this information. For packaged products, this includes everything from ingredient lists and nutritional information to packaging design and labeling. Content must be created and approved swiftly and accurately, often involving multiple stakeholders, making the management process complex.

To prevent recalls effectively, a solution should address the following key areas:

1. Centralized Information Repository: A centralized platform ensures that all packaging content is stored in one location, reducing the risk of errors and making it easier to track changes and updates. This central repository should support version control and audit trails to maintain a clear history of all content modifications.

2. Automation: Automation is crucial for reducing manual errors and speeding up the content management process. Automated workflows can handle repetitive tasks such as generating artwork, applying changes, and searching for content.

3. Error-Free Collaboration: Effective label and artwork management requires seamless collaboration among various stakeholders, including marketing, legal, regulatory, and design teams. However, when many teams are involved in editing and re-working content, it can be easy for errors to arise. Look for software that prevents these errors by flagging up mistakes.

4. Regulatory Compliance: Keeping up with regulatory requirements, such as the EU MDR, new Windsor Framework regulations, or the latest EU CLP updates, is vital to prevent recalls. A good digital solution should have tools and functions that make it quick and easy to automatically update content to meet the latest regulations despite tight deadlines.

5. Comprehensive Reporting, Version Control Management, and Approval Processes: Insightful reporting and effective approval processes help to monitor the performance of your process and ensure that the correct labels are printed every time. Look for software that provides detailed reports, version control management, and highly reliable approval processes.

6. User-Friendly Interface: A user-friendly interface ensures that all team members can use the software effectively without extensive training. The interface should be intuitive, with clear navigation and easy access to all essential features.

7. Scalability: As your business grows, your content management needs will evolve. Choose a solution that can scale with your business, accommodating an increasing volume of content and more complex regulatory requirements.

Choose Veraciti™ to ensure your labels and artwork are right first time, every time

At Kallik, we understand the critical importance of product safety and recall prevention. Imagine being able to create, review, and approve content for labels and artwork with complete confidence that you are 100% compliant. With our advanced digital solution, Veraciti™, you can make this a reality, just as Integra LifeSciences did. Since implementation more than five years ago, Integra reports it has not had a single issue with compliance. “We are delighted with our 100% success rate that Kallik helps us to deliver,” Senior Marketing Operations Manager, David Dreibelbis, enthuses.

Veraciti has also enabled Teleflex to completely mitigate product recalls thanks to the centralized cloud-based system. End-users benefit from standardized labeling processes and powerful features such as a dedicated asset search engine, enhanced phrase and translation management and end-to-end approval and audit trails.

What to expect from Veraciti™

Innovative, automated tools and functions such as the ‘Where Used’ function, the Rules Engine and Automated Artwork Generation (AAG).

Industry leading artificial intelligence (AI) driven technology such as Veraciti’s Assisted Technology of Migration (AToM).

As a truly end-to-end platform, Veraciti™ minimizes the need for input from multiple teams and external companies, ensuring a more seamless, efficient and error-free process. This also provides detailed audit trails at every step, enhancing transparency and accountability throughout the entire workflow.

How Veraciti™ Helps Prevent Recalls and Saves Lives

By investing in Veraciti™, you not only protect your brand and products but also safeguard the lives of your consumers. Accurate and consistent packaging content ensures that consumers receive the correct information, preventing potentially life-threatening mistakes. In doing so, Veraciti™ plays a crucial role in saving lives every day.

Don’t let a recall damage your brand’s reputation and endanger the lives of your consumers. Get in touch with us today to learn more about how Veraciti™ can help prevent product recalls and contribute to saving lives.

Want to Know More?

Why not speak to one of our labeling and artwork experts to learn more about how Veraciti™ can help your business to transform its product packaging process with the very best labeling and artwork management? Get in touch today at enquiries@kallik.com or call +44 (0) 1827 318100.
 

When it comes to mergers and acquisitions, enterprise organizations face a myriad of challenges when integrating new products into their portfolios. From streamlining product integration to ensuring regulatory compliance and managing complex audit processes, the task can seem daunting. However, with the right tools and strategies in place, organizations can navigate mergers with ease, ensuring a seamless transition and unlocking new opportunities for growth. Enter Veraciti, a trusted partner in label management solutions, dedicated to simplifying the complexities of mergers and acquisitions for enterprise organizations. That’s where our end-to-end enterprise labeling and artwork software, Veraciti, can help.

Streamlining Product Integration:

One of the biggest challenges in mergers and acquisitions is integrating new products into existing portfolios seamlessly. Veraciti offers a comprehensive suite of tools and features designed to streamline this process. From automated artwork generation to centralized label management, Veraciti enables organizations to bring 100 new products on board with ease, minimizing disruptions and maximizing efficiency.

Rapid Name Changes:

Veraciti makes it quick and easy to change company names, brand names and company ownership of brands,thanks to our Automated Artwork Generation (AAG) tool and label templates. Gone are the days of hiring a team to spend months manually changing labels and artwork if your company undergoes a re-brand or merger, instead you can execute name changes in as little as 10 seconds with Veraciti. AAG ensures accuracy by maintaining one single, company and/or brand name, approved address and logo, automatically updating hundreds of labels in minutes.

Streamlined Logo Management:

Veraciti simplifies logo management by vectorizing logos, regardless of their size variations. With only one copy of each asset, resizing logos becomes effortless without compromising quality. This centralized approach also makes logo management easier and more efficient.

Automated Inspection:

Veraciti significantly reduces the need for manual inspection by utilizing automation to increase accuracy. Unlike other platforms where each label must be opened individually for inspection, Veraciti allows for sample checks, saving time and resources while maintaining precision.

With Veraciti, companies can navigate all of the usual complexities that come with mergers and acquisitions with ease, ensuring swift and accurate updates across all products and labels.

Ensuring Regulatory Compliance:

With regulatory requirements becoming increasingly stringent, ensuring compliance across a diverse range of products is paramount. Veraciti's robust compliance management capabilities help organizations navigate regulatory complexities with confidence. By providing real-time insights into labeling requirements and facilitating bulk changes seamlessly, Veraciti ensures that organizations remain compliant with industry standards throughout the merger process.

Scalability Made Easy:

One of the key benefits of partnering with Veraciti is scalability. As organizations undergo mergers and acquisitions, the need for scalable solutions becomes more pronounced. Veraciti's cloud-based deployment ensures that organizations can scale their label management capabilities effortlessly, accommodating new products and expanding operations with ease.

Case Study: Aspen's Success Story:

A 20-year-old major surgical device manufacturer comprised of 18 acquisitions, recently turned to Veraciti to standardize label printing across all factories. During Veraciti's implementation, Aspen brought on two more companies, seamlessly integrating them into the original project with no time overrun. Thanks to Veraciti's cloud deployment, the enterprise was able to add new companies with ease, demonstrating the scalability and efficiency of Veraciti's solutions.

So there you have it - navigating mergers and acquisitions doesn't have to be a daunting task. With Veraciti's comprehensive suite of label management solutions, organizations can streamline product integration, ensure regulatory compliance, manage audit and approval processes, and scale their operations with ease. By partnering with Veraciti, enterprise organizations can navigate mergers with confidence, unlocking new opportunities for growth and success.

Want to know more about how Kallik can help you? Download our free guide on labeling and artwork trends in 2024 to get started on transforming your cosmetic labeling and artwork management. Speak to one of our labeling and artwork experts for more information by emailing enquiries@kallik.com, calling +44 1827 318100 or filling in the form here.