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1499 Search result(s):
Regulatory Due Diligence  
Our comprehensive regulatory evaluation provides you, as an investor or buyer, with a clear basis for your investment decision.  
FDA Inspection & Remediation  
With our support, you will pass FDA inspections successfully and quickly eliminate deviations in remediation.  
Risk Management  
Pass approvals, audits, and reviews quickly and easily with legally compliant risk management files and safe medical devices.  
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.  
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.  
Results 331 until 340 out of 1499
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