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1352 Search result(s):
Electrical Safety & EMC  
Quickly obtain compliant documentation to demonstrate electrical safety or electromagnetic compatibility as a medical or IVD medical device manufacturer.  
Biological Safety  
We help you demonstrate the biological safety of your medical devices without unnecessary effort and document it in a compliant manner.  
Usability  
Fast track to FDA and IEC 62366-1 compliant usability files for medical and IVD medical device manufacturers.  
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.  
Guided Clinical Evaluator  
Discover the Guided Clinical Evaluator – your solution for the autonomous creation of clinical evaluations.  
Biocompatibility  
The fast track to ISO 18562, ISO 10993, and FDA-compliant biocompatibility files for medical and IVD medical device manufacturers.  
Reprocessing Validation  
Our experts help you reprocess your medical devices in compliance with the law – quickly and safely validated.  
IVDR Expert Session  
With the IVDR expert session, you gain clarity on the qualification of your in-vitro diagnostic medical devices and the best approval strategy in only one hour.  
Post-Market Radar  
The Post-Market Radar takes over continuously monitoring the relevant notifications for your medical devices.  
Regulatory Radar Book Demo  
Book your free & non-binding live demo for the Regulatory Radar now Our expert from the Johner Institute will guide you through the intuitive user interface and show you how you can use the database…  
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