Urs Muller's Colleagues at Johner Institut GmbH
Christian Rosenzweig
Consultant Medical Devices bei Johner Institut GmbH
Annett Arndt
Senior Consultant for Technical Documentation and Quality Management Systems
Andreas Kalchschmid
Consultant for In Vitro Diagnostic Medical Devices and Quality Management Systems
Urs Muller's Contact Details
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Johner Institut GmbH
Urs Muller's Company Details
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