News & Media

In its bid to comply more readily and effectively with ever-evolving safety and quality standards, internationally, from EMA’s implementation of ISO IDMP to new FDA Pharm Quality/CMC specifications, the pharma industry could learn a lot from medical device manufacturers about effective enterprise labelling change management across the lifecycle of products.

Looking for a more secure and cost-effective way to label you products? Have a read of what our VP Product Strategy, Seth Kane, has to say about the benefits of e-labelling when it comes to label accuracy in this article.

The pharmaceutical industry may well have a head-start on compliance with product transparency requirements, after years of fulfilling strict market regulations around accurate and safety-oriented labeling. Yet medical device manufacturers have the advantage of an engineering mindset, which lends itself to a modular approach to preparing and managing labeling content globally in a reliable and efficient way - best practice which could benefit adjacent industries…

The transition some medical device manufacturers face with the new EU Medical Device Regulation (EU MDR) labeling requirements may seem overwhelming. Here, Bob Tilling outlines how you can waste no time in preparing your labeling operations for compliance ahead of the upcoming deadline.

"For some manufacturers of medical devices, the EU MDR delay to 2021 may come as good news in a time of widespread business disruption. But manufacturers should not use the extension of the regulation as an excuse to ignore making operational changes until just before the deadlines – rather, they should see it as an opportunity to properly prepare operations for increased compliance." Read what our VP Global Sales, Bob Tilling, has to say about the impact of the EU MDR extension in this article.

In highly regulated industries, your labelling must speak for your product, says Beth Peckover, VP of Global Delivery at Kallik.

As new device identification and traceability measures become compulsory in 2020, under the new EU Medical Device Regulation, Bob Tilling, new business development manager at Kallik, explores the residual issues that remain for manufacturers.

Read all about our incredible 2020 software statistics and the benefits of using Veraciti for your label and artwork management in this PharmiWeb article.

As regulatory changes, public demand and pure economics drive more labelling content online, what are the considerations for managing all of this? Kallik’s Graham Francis offers some best-practice advice.

Read all about our transition to the AWS cloud and the benefits of this for our customers in this article.