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Johner Institut GmbH
#audit
#elearning
#seminars
#clinical evaluation
#clinical investigation
#regulatory updates
#post-market surveillance
#technical documentation
#quality management
#risk management
Overview
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
Contact Details
info@johner-institut.de
Konstanz, Germany, Reichenaustraße 39a
+2
Founded
2005
Employees
100-150
Keywords
#audit
#elearning
#seminars
#clinical evaluation
#clinical investigation
#regulatory updates
#post-market surveillance
#technical documentation
#quality management
#risk management
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