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Usability Engineering  
Our free quick guide helps you implement the usability process in compliance with IEC 62366-1, avoid costly rounds of revisions, and successfully pass MDR and FDA audits.  
Biocompatibility Checklist  
Avoid delays in MDR approval: How to request biocompatibility data in accordance with ISO 10993-1:2025.  
Our Locations  
Where to Find Us: The Johner Institute is Represented Internationally at Several Sites in Europe and the USA  
Software & (IVD) Medical Devices with AI  
We help you to efficiently develop and successfully approve your software medical devices and IVD software – including AI-based medical devices.  
Risk Management  
Pass approvals, audits, and reviews quickly and easily with legally compliant risk management files and safe medical devices.  
Post-Market Surveillance, Post-Market Clinical Follow-up, Post-Market Performance Follow-up  
Fast and compliant documentation of your Post-Market Surveillance (PMS), PMCF, or PMPF, which you can submit right away.  
IVD Performance Evaluation  
Quickly and safely pass approval, audits, and technical reviews with legally compliant IVD performance evaluation files.  
Contact  
You can reach us via various channels – by email, phone, or web form. We look forward to hearing from you and will get back to you as soon as possible.  
Shelf Life and Transportation Validation  
We help you with the shelf-life testing and transport validation of your medical devices – from the planning stage to compliant documentation.  
It Security  
Quickly and safely pass approval, audits, and reviews with legally compliant cybersecurity files and IT-secure devices.  
Results 1 until 10 out of 585
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