Biologics Consulting

FDA

Biologics Consulting is a Virginia-based, employee-owned regulatory consultancy founded by former FDA officials. Its medical device team supports regulatory strategy, due diligence, FDA meetings, submissions, quality systems and software-procedure reviews. The wider firm also works with biologics, pharmaceuticals and combination products, giving device developers access to consultants with experience across multiple FDA centers and product categories.

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Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months 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

List of Medical Device Consultants

Sven Piechottka

updated over 2 years ago