Regulatory Pathways Group

FDA EU MDR

Regulatory Pathways Group is a California consulting firm with a multidisciplinary team covering regulatory, clinical, quality, statistical and medical-writing work. Its medical device services include FDA Pre-Submissions, 510(k), De Novo, IDE and PMA filings, agency strategy and human-factors support. The firm also develops EU MDR strategies and submissions, clinical evaluation reports, literature reviews and technical documentation for CE marking.

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FDA Compliance

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Updated about 1 year ago

Sebastian Skorka

How is medical device regulation developed and how can its usability be improved for start-ups?

Anonymous · 1 comment

about 1 year ago

I am interested in understanding how medical device regulation, specifically the MDR, is developed and what could be done to improve its usability, especially for small start-ups. From my experience a

Accepted 3 answers

Regulation like the MDR is developed at the EU level as part of the "new legislative framework" for product safety. The process involves EU institutio

8:09

ChatGPT For Medical Device Documentation (MDR / FDA)?

Dr. Oliver Eidel

785 views · over 2 years ago