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Lighthouse Regulatory Consulting

FDA

Lighthouse Regulatory Consulting is a US medical device practice founded and led by Bahram Parvinian, a former FDA device reviewer. It advises manufacturers across product development, testing, regulatory submissions and post-market performance. Its FDA work covers 510(k), De Novo, IDE and PMA pathways, with particular experience in life-supporting devices, automated drug delivery, physiological monitoring and other digital health technologies.

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Medizinprodukteberater Course: Requirements, Tasks, Responsibilities 10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago
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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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Notified body

Kiwa Dare

2 reviews · updated over 2 years ago