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Imprint  
Imprint Legal References The Johner Institute North America Inc is a United States of America based enterprise. Contacts Johner Institute North America Inc. 1738 Elton Rd., Suite 138 …  
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Inhouse Seminars: Trainings tailored to your needs  
Inhouse Seminars: Trainings tailored to your needs If you want to book one of the seminars exclusively for your company, please get in touch with us. We are happy to adapt the seminars to your…  
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Starter-Kit  
Getting an overview of regulations and standards is a headache for you? We help you from the very beginning.... The Johner Institute Starter Kit If you’re just beginning the approval process,…  
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Prof. Dr. Johner  
Prof. Dr. Christian Johner Christian Johner is passionate about software development, medicine, quality management and teaching. His missions are to encourage those, who work in combined field…  
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Page not found  
Ooops, we lost a Page!? Some people speak of a 404 error… We are sorry! The page you are looking for doesn’t exist (anymore). Were you looking for Support with developing and authorizing…  
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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.  
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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…  
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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%…  
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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  
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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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