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1352 Search result(s):
Usability Evaluations  
Pass approval quickly and safely with IEC 62366-1 and FDA-compliant usability evaluations, thanks to the Johner Institute's usability services.  
Electrical Safety & EMC Testing  
Quickly and safely pass approval with internationally compliant safety and EMC tests.  
Biocompatibility Testing  
Quickly and safely pass approval with ISO 18562, ISO 10993, and FDA-compliant biocompatibility testing.  
IVD Performance Evaluation  
Quickly and safely pass approval, audits, and technical reviews with legally compliant IVD performance evaluation files.  
Clinical Evaluation  
Pass approvals, audits, and reviews quickly and safely with legally compliant clinical evaluations. Thanks to our clinical affairs services.  
IT Security  
Quickly and safely pass approval, audits, and reviews with legally compliant cybersecurity files and IT-secure devices.  
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.  
Auditing  
Prepare yourself optimally for an upcoming external audit of your management system - with ISO-compliant internal system or process audits.  
Feedback of our Customers: Silvia Henke, Alsitan GmbH  
Silvia Henke, Alsitan GmbH As a medium-sized company, the Auditgarant helps us to ensure that our documents comply with MDR and to identify any gaps. We benefit greatly from the expert sessions and…  
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…  
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