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
Company Details
- Employees
- 114
- Founded
- -
- Address
- Reichenaustraße 39a, Konstanz,baden-Württemberg 78467,germany
- Phone
- +49 7531 94500 20
- in****@****itut.de
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- https://www.johner-institut.de
- Keywords
- 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, Product Testing.
- HQ
- Konstanz, Baden-Württemberg
Johner Institut Gmbh Questions
Johner Institut Gmbh's helpline number is +49 7531 94500 20
Johner Institut Gmbh's website is https://www.johner-institut.de
Johner Institut Gmbh's LinkedIn profile is https://de.linkedin.com/company/johner-institut-gmbh
Johner Institut Gmbh has
114 employees.
View email and phone details for 114
employees at Johner Institut Gmbh.
Johner Institut Gmbh's industry is
Business Consulting and Services
Johner Institut Gmbh's top competitors are
Medicalmountains Gmbh,
Johner Institute North America Inc.,
Metecon Gmbh,
Bvmed - Bundesverband Medizintechnologie,
Regulatory Affairs Professionals Society (Raps),
B. Braun Group,
Löwenstein Medical,
Karl Storz,
Qtec Services Gmbh,
Medtech Europe.
Johner Institut Gmbh's support email address is info@johner-institut.de
Johner Institut Gmbh's categories are Business Consulting and Services
Johner Institut Gmbh's founding year is 2005
