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BioDesign Regulatory Services

FDA

BioDesign Regulatory Services is a US consultancy founded and led by principal consultant Alex Chang. The practice develops FDA regulatory strategies and prepares submissions for medical devices, diagnostics, pharmaceuticals and biologics. Its documented device work includes 510(k) and PMA submissions, IVD projects, quality management systems, design controls, risk management and support for companies that need an official US agent.

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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

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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

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities 10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago