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1499 Search result(s):
MDR Expert Session  
Our one-hour MDR expert session will clarify the qualification of your medical device and the best approval strategy.  
Readiness Check  
Be on the safe side with our readiness check and accelerate your MDR/IVDR conformity assessment with a notified body.  
Technical Documentation  
We help you to quickly and safely get your medical and IVD medical devices approved with complete technical documentation that complies with the law.  
Change & Transformation Projects  
Consulting for medical device manufacturers regarding change and transformation projects – prepare your regulatory affairs department for tomorrow.  
Computerized Systems Validation  
We help you set up a lean CSV process to validate relevant computer systems and document them in a regulatory-compliant manner.  
International Approval  
International approval of medical devices: Bring your medical or IVD medical device to all markets in the world in a predictable and safe manner in accordance with all regulatory requirements.  
US Market Access  
Bring your medical and IVD medical devices to market in the USA in just a few months through the 510(k) or De Novo Procedure.  
Regulatory Strategy  
We help you develop the right regulatory strategy so that your medical devices can be approved quickly and safely in the desired market.  
Performance Evaluation Strategy for IVD Medical Devices  
We help you develop a targeted performance evaluation strategy that is optimally suited to the intended purpose of your in-vitro diagnostic medical devices.  
In-house Production of IVD Medical Devices  
Achieve IVDR compliance for your health institution (e.g., your medical laboratory) and your in-house IVD medical devices in the shortest possible time.  
Results 321 until 330 out of 1499
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