Johner Institut GmbH
Effortlessly navigate the medical device approval processes and market and quickly market your device world-wide.
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Company intel
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- Business Consulting and Services
- Company size
- 95 people
- Headquarters
- Konstanz, Baden-Württemberg +2 more
- Founded
- 2005
- Type
- Public Company
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, artificial intelligence - 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
