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As the manufacturer of a medical device, you are responsible for the manufacturing process. This seems like an obvious statement, but sometime the manufacturing operation might be in another country, on another continent, or even conducted by an entirely separate organisation. However, if it’s your company’s name on the box – then you are the manufacturer in the eyes of the FDA.

With that responsibility comes the duty of ensuring that the manufacturing process consistently produces parts to the design intent. It is often very costly or even impossible to verify that every part manufactured meets the design intent. For example, measuring every dimension on a complex assembly, or ensuring every moulding is void free. This is when validating the process helps.

Following a stepwise process, documenting requirements, factory acceptance testing (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) might seem overly burdensome, however it pays dividends with providing confidence and peace of mind.

As a design authority – request this documentation from your manufacturing sites.

As a manufacturing site – ensure before you switch on manufacturing process that it is truly capable.

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