FDA Quality System Regulations and Design Control

The FDA has some very useful information at its website www.fda.gov for any corporation that wants to create medical devices and needs to learn the requirements.  I would recommend this webpage to any engineer whose job depends on meeting FDA requirements.  As I understand it if a medical product fails and injures people everyone in the corporation responsible for creating and signing off on it from the CEO to the engineering technologist is open to legal action by the Federal Government.  Knowing what the FDA needs first hand is therefore useful when attempting to meet corporate interpretations of the FDA requirements and to keep out of trouble.  The documents can be a bit difficult to read in places but for the most part are written rather clearly.  I find the “Medical Device Quality Systems Manual: A small Entity Compliance Guide” very useful since it is geared to smaller businesses.

Start here: Overview of Device Regulations

Then here:

Quality Systems Regulation (QSR)/Good Manufacturing Practices (GMP)


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