Consultant for In Vitro Diagnostic Medical Devices and Quality Management Systems at Johner Institut GmbH - Reichenaustr. 1 Konstanz, N/A, DE
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