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Bettina Martin Email
Head Clinical and Safety Affairs . Johner Institut GmbH
Konstanz,
Locationb*************@johner-institut.de
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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 updateJohner Institut GmbH Address
Villa RheinburgKonstanz, null
GEN