EU Medical Device Regulation (MDR) – The Useful Guide to Labeling Compliance

The new regulation  is a fundamental revision to better control and identify medical devices products and improve safety and transparency through clear accountabilities, standard processes and data, technological advances and the establishment of an EU database (Eudamed).

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Can Vision Systems safeguard label integrity?

Medical device and pharmaceutical organizations are constantly looking at ways to avoid labeling errors which are a major reason for FDA product recalls.

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How one client saved $8M using PRISYM IDs print-on-demand solution

PRISYM ID’s print on demand solution, has enabled this blue chip medical device provider to print single-language Instructions for Use (IFU) at the time of shipment. This means that rather than their manufacturing sites including 23 Language IFUs with the product, they can instead print a country-specific IFU based on the intended destination of each product, and add it to the package at the time of shipment.

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Survey results show labeling is critical to medical device companies

A 2015 survey carried out by PRISYM ID into the key labeling challenges for the medical device and life sciences industries, has identified regulatory compliance and supply chain efficiency as the key drivers for organizations needing to change or adapt their packaging and labeling operations.

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