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Sanrubio Medical Devices Consulting

FDA

Sanrubio Medical Devices Consulting is a Miami-headquartered firm focused on US market access for medical device manufacturers. Its multidisciplinary team develops FDA regulatory strategies and prepares 510(k), De Novo and Pre-Submission documentation in eSTAR formats. It also supports establishment registration, device listing, US-agent representation, technical-document gap reviews and quality systems aligned with FDA requirements and ISO 13485.

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Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation) 7:52

Post Market Clinical Follow-up: The Report (Medical Device Clinical Evaluation)

Dr. Oliver Eidel

14 views · 8 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

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities 10:40

Medizinprodukteberater Course: Requirements, Tasks, Responsibilities

Dr. Oliver Eidel

30 views · 7 months ago