ISOplan USA

FDA

ISOplan USA is the Daytona Beach office of a medical device consulting group with operations in the United States and Europe. Its consultants support medical device and IVD manufacturers with FDA clearance strategy, establishment registration and listing, US-agent representation, clinical-study planning and quality-system compliance. The firm works with both startups and multinational manufacturers seeking access to the US market.

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FDA Compliance

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Updated about 1 year ago

Sebastian Skorka

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

16:05

Human Resources Administration For Medical Device Companies (ISO 13485)

Dr. Oliver Eidel

21 views · 9 months ago