LABEL MANAGEMENT SOFTWARE
Improve FDA & EU compliance
Minimize risks & product recalls
Increase traceability & auditability and more…
MEDICAL DEVICE LABELING
The importance of medical device labeling has increased significantly since PRISYM ID developed its first URS for a validatable enterprise labeling solution with a major global medical device manufacturer (and long-standing client) in 1999.
A broader view of the labeling procedures is essential. In the battle to deliver safe, accurate and compliant product information, it’s not just about the quality of the label – it’s also about the data. By implementing a lifecycle label management solution supported with up to date validation documentation based on the GAMP 5 Model, you can ensure peace of mind.
The size of the organization does not matter — the FDA and other regulatory bodies do not draw distinctions - so SME organizations also have to take a strategic approach to the management of their data and that is where we can help with our scalable and validatable labeling solutions.
The European medical device industry is in the grip of the biggest changes the market has seen in decades.
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This solution provides organizations with complete label integrity to meet the strictest compliance requirements for FDA & EU regulations, specifically FDA 21 CFR Parts 11, 810, and 820.
MEDICAL DEVICE LABELING RESOURCES
EU MDR Labeling Compliance: Learn the Lessons from UDI. Date: 05 December 2017; 3PM GMT / 4PM CET
Whether you’re producing medical devices within Europe or supplying to Europe from the rest of the world, as a manufacturer or supplier, you will need to adhere to the EU MDR by May 2020.