Ganymede Consulting GmbH
www.gany.chConsultancy to the medical device industry, with a focus on design verification, device certification (CSA, CE etc), computer system validation, process validation and software validation. Deep understanding of ISO13485, CFR 820, particularly .30 and .45. and the FDAs UDI (Unique Device Identification) System.
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Consultancy to the medical device industry, with a focus on design verification, device certification (CSA, CE etc), computer system validation, process validation and software validation. Deep understanding of ISO13485, CFR 820, particularly .30 and .45. and the FDAs UDI (Unique Device Identification) System.
Read more
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