Nu Device Consulting LLC

FDA

Nu Device Consulting LLC is a North Carolina practice led by regulatory consultant and engineer Jean Bigoney. It prepares and submits FDA 510(k) applications for domestic and international medical device manufacturers, advises on responses to refuse-to-accept and additional-information requests, and develops tailored US regulatory strategies. The practice also provides US-agent, FDA establishment-registration, device-listing and state-registration support.

Learn more

List of Medical Device Consultants

Sven Piechottka

updated over 2 years ago

Are there FDA requirements for non-device clinical decision support software?

Anonymous · 1 comment

5 months ago

According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the US market? Are there st

Accepted 1 answer

If your assessment shows that your product is truly a “non-device” according to the FDA guidance, there aren’t specific FDA requirements you need to m

Can anyone recommend a consultant with experience writing a CIP for a Class IIb device?

Anonymous

8 months ago

Could anyone refer any freelance consultants in this community that have experience writing a Clinical Investigation Plan (CIP) for a Class IIb medical device? I might have an interesting opportunity

No answers yet