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1478 Search result(s):
Feedback of our Customers: Joachim Köninger, HeartGo GmbH  
Joachim Köninger, HeartGo GmbH Both the reference to the document templates in the Auditgarant and the ongoing updates in the newsletter and on the Johner Institute blog were very helpful during the…  
Feedback of our Customers: Frank Münzinger, Aignostics GmbH  
Frank Münzinger, Aignostics GmbH The Auditgarant helped us to set up our QMS within six months. The temp­lates ensured that we took into account not only the requirements of ISO 13485 but also those…  
Feedback of our Customers: Melanie Henze, Preventicus GmbH  
Melanie Henze, Preventicus GmbH With the help of the Auditgarant, we were able to successfully complete our MDR approval compliance process. We are grateful for the high-quality templates and…  
Feedback of our Customers: Matthias Hippe, Mediceo GmbH  
Matthias Hippe, Mediceo GmbH As a young company without much background in the field of regulatory requirements for medical devices, we were faced with the major challenge of creating the framework…  
Feedback of our Customers: Anja Discher, DISCHER Technik GmbH  
Anja Discher, DISCHER Technik GmbH We are very happy that we did so well in our MDR audit. The auditor said that this is very rare. Investing in the Auditgarant was well worth it! Many thanks to the…  
Feedback of our Customers: Sabine Dörner, EyeSense GmbH  
Sabine Dörner, EyeSense GmbH The Johner Institute's Auditgarant was a great help with our first submi­ssion. Thanks to the e-learning, the comprehensive templates, and the always helpful team, we…  
Feedback of our Customers: Max Power Life Science GmbH Team  
Max Power Life Science GmbH Team We are a newly founded com­pany striving for ISO 13485 certification. First of all, the Johner Institute's Auditgarant convinced us. In an industry subject to strict…  
Usability Evaluations  
Pass approval quickly and safely with IEC 62366-1 and FDA-compliant usability evaluations, thanks to the Johner Institute's usability services.  
Summative Evaluation  
Meet the requirements of IEC 62366-1 and FDA with summative evaluations and thus create the prerequisites for the rapid approval of medical devices, IVD medical devices, and combination products.  
Subject Recruitment  
We take care of recruiting healthcare professionals for your usability studies, from the search to the support on the day of the test.  
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