510k vs MDR FAQ
What is the difference between FDA and EU MDR regulations for medical device approvals? How do they differ? What are the requirements?
We answer these questions and more…
FDA 510k transition
Supporting an FDA 510k to MDR transition
This case study looks at supporting an FDA 510k to MDR transition and how CLIN-r+ supported one manufacturer’s journey to enter the European market by leveraging their FDA 510k certificate.
Translating your FDA 510K to an EU MDR submission
Starting an EU MDR gap analysis of your FDA 510K submission early on will speed up your progress in both the US and EU markets. FDA and MDR definitions differ. Clin-r+ advises on how they compare.
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