FDA UDI, EU MDR, FDA 21 CFR Part 11
regulations compliance can be easily achieved
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How we can help with Medical Device Regulation (EU MDR)
The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of EU MDR.
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EU MDR introduces additional information that needs to be included on labels, forcing organizations to design new label templates that make room for data not previously part of the labeling system.
Whether you’re producing medical devices within Europe or supplying to Europe, as a manufacturer or supplier, you will need to adhere to the new EU MDR.