Search results with tag "Guidelines for regulatory auditing of quality systems of medical device manufacturers"

Reporting of design changes and changes of the quality system

(iii) in the case of design / device changes, a statement on the relevance to the compliance with the essential requirements. 4 Notified Body surveillance and certification (see also “Global Harmonization Task Force Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers“, section Special audits

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