About
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.
Technologies
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Keywords
ce etc support
unique device idenification support
device certification csa
medical device design verification
software validation
process validation
computer system validation
medical equipment manufacturing
medical devices
hospital & health care
Company Information
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Employees 2
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Founded 2010
Location
Huenenberg, Canton of Zug, Switzerland
