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Market your medical device  
Learn with 50+ instructional training videos how to compile a technical file to market your medical device fast and compliant with FDA and European regulations.  
Technical Documentation  
Technical Documentation Medical device manufacturers have to prove compliance of their products to US and European authorities (FDA respectively notified bodies). Technical File: The…  
Human Factors Engineering  
Human Factors / Usability Engineering and Usability Testing in Europe and the US Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass FDA approval with 100%…  
Checklist Software Requirements Specification  
The SSRS checklist prepares to for FDA submissions and CE-approvals. Evaluate whether your SRS is FDA and IEC 62304 compliant  
Privacy Policy  
Privacy Policy Last updated: 28/03/2022  Basic information on data processing and legal basis This data protection statement explains to you the type, scope and purpose for the…  
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Medical Device Briefings  
Medical Device Briefings Stay informed with our newsletter The Johner Institute's newsletter keeps you updated on changes affecting the medical device and IVD industry. Get best practices and…  
Services  
Our Services Our Services Learn more about our services by following the links below. Human Factor Engineering Create IEC 62366-1 and FDA-compliant usability files in no time at all. Pass…  
Regulatory affairs: support for the international approval of medical devices  
Regulatory affairs: support for the international approval of medical devices Would you like to bring your medical products to market worldwide (in Europe, the USA, China, etc.) quickly, safely…  
Seminar Overview  
Welcome to the seminars at the Johner Institute With the seminars at the Johner Institute, you get first-hand knowledge. Knowledge proven in practice that you can implement directly in your…  
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