FDA 510(k) Applications for Medical Devices

By: Sierra Labs on 06/04/20 11:41

A Simple Guide to 510(k) Applications for Medical Devices

Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
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Regulatory Approach for Software Functions

By: Sierra Labs on 05/07/20 9:09

A Regulatory Approach Manual for Device Software Functions

Understanding the policies for your Medical Device Software Functions
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