The Jans Group LLC

FDA EU MDR

The Jans Group LLC is a North Carolina practice founded by regulatory consultant Michele Jans. It authors and submits medical device 510(k), PMA, Pre-Submission and IDE filings, develops US regulatory strategies and supports FDA correspondence. Its European services include EU MDR technical documentation, clinical evaluation reports, notified-body interactions, device labeling and vigilance activities for medical devices and IVDs.

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Dr. Oliver Eidel

103 views · over 2 years ago

Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software

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