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.

Learn more

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

How can the usability of the MDR and related standards be improved for startups?

Anonymous · 1 comment

6 months ago

One user described difficulties in applying the Medical Device Regulation (MDR) and related standards, especially as a startup. The user finds the regulations and standards difficult to read and under

Accepted 4 answers

Great question! I think improving the usability of the MDR and related standards is a big challenge, especially for startups. The MDR is law and ISO s