What to do if you get an FDA Recall

Data shows that more than half of all FDA recalls of medical devices have been caused by packaging and/or labeling errors. What is the best way to survive an FDA recall? Make sure you are compliant not only by fixing the recall issue, but preparing for the future.

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Survey reveals that only 17% of the respondents are aware of the changes that come with the EU MDR

Here at PRISYM ID, we have recently conducted a survey of international medical device manufacturers, to ascertain their understanding of EU MDR, and the implications of the new regulation on label lifecycle management. Read More

Color Label Printing At Your Fingertips

The idea of color printing labels on demand has been thrown around the medical device and pharmaceutical market for many years but in reality, most organizations rely on the traditional two-stage color label printing process they know – batch print and over print. But here lays the problem, huge amounts of label stock on the shelf can be costly and quite often wasted.

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Clinical Trials: Managing Labeling Approvals with Multi-Language and Multi-Region Regulations

The clinical trial market is not only global, today it touches more markets than ever before. Increasingly, a key component of this is the need to comply with variable local language labeling requirements, not least in the safe distribution of medicines for clinical trials. With the global map for clinical studies now extensive, information to support the safe and effectual use of trial medicines must be coherent and understandable to the patients receiving them.

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Clinical trials: when the label became more significant than the drug itself…

The importance of labeling in clinical trials gets very little exposure. However, as the global war for patients intensifies in an increasingly competitive trial market, and with subject attrition rates commonly shown to be between 15-20%, pharmaceutical companies are slowly discovering that the packaging of their products can be a key determinant of patient retention.

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Top three challenges in Clinical Trial packaging and labeling operations

During our recent webinar ‘Future proofing your Clinical Supply Chain’, co-presented by myself and Jason James, Senior Manager, Labelling & Innovation, Bristol-Myers Squibb, we discussed some of the drivers for change in Clinical Research today as well as the impact of these changes on clinical trial supply chain, particularly packaging and labeling operations. Read More

Analyzing Best Practices in Lean Labeling for Global Efficiency & Regulatory Compliance

Last week (29th & 30th September), over 40 speakers from across the medical device industry came together to discuss the latest trends, issues and best practices in optimizing medical technology labeling and packaging. Read More