Johner Institute helps medical device manufacturers to 

- compile, review and improve technical documentations: risk management files (ISO 14971), usability files (FDA, IEC 62366-1), software documentation (FDA, IEC 62304), physical safety (IEC 60601-familiy), clinical evaluations

- establish, audit and improve quality management systems (ISO 13485, 21 CFR part 820)

- perform usability testing in Europe and the USA

- plan and conduct clinical investigations

- perform post-market surveillance, regulatory affairs update

Johner Institut GmbH

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