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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 update
Audit,elearning,seminars,clinical evaluation,clinical investigation,regulatory updates,post-market surveillance,technical documentation,quality management,risk management,iso 14971,ce marking,medical device approval,510(k),iec 62304,iec 62366-1,usability testing,human factors engineering,mdr,ivdr,iso 13485,fda,human factors engineering,electrical safety,it-security,and product testing
Johner institut gmbh operates in the Business consulting and services industry.
Johner institut gmbh's revenue is 11m - 100m
Johner institut gmbh has 51 - 200 employees.
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