- QMS Part 2
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- For all but the lowest risk devices, the manufacturer will need to implement a QMS. In the US, compliance with the Quality System Regulation (QSR) detailed in 21 CFR 820 is required for the majority of devices - even some Class I devices. In Europe, compliance with one of the QMS annexes (equivalent to EN ISO 13485) of the appropriate medical device Directive is required except for Class I devices
- While the clinical study is underway it is the ideal time to turn your management's attention to completing implementation of the selected QMS., expanding it beyond design controls to include such areas as manufacturing, service, CAPA, etc. By the time the investigation is complete, you should have the necessary QMS certification to allow the device launch and subsequent marketing
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