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1352 Search result(s):
Clinical Investigations & Studies  
We help you to achieve your market approval with lean clinical investigations.  
IVD Performance Studies  
We help you ensure the quality of your analytical and clinical performance studies for in vitro diagnostic medical devices and their results.  
Formative Evaluation  
Accelerate the development and approval of medical devices, IVD medical devices, and combination products, and improve product safety through formative evaluations.  
Summative Evaluation  
Meet the requirements of IEC 62366-1 and FDA with summative evaluations and thus create the prerequisites for the rapid approval of medical devices, IVD medical devices, and combination products.  
Marketing Claim Study  
Prove your marketing claims quickly and credibly with marketing claim studies and thus boost the marketing of your medical devices, IVD medical devices, and combination products.  
Usability Lab Rental  
Usability lab rental for medical and IVD medical device manufacturers for successful usability studies and usability tests.  
Subject Recruitment  
We take care of recruiting healthcare professionals for your usability studies, from the search to the support on the day of the test.  
Legal Manufacturer  
We are your legal manufacturer and take full regulatory responsibility for your medical devices in Europe.  
Quality Management Representative  
As your experienced external quality management representative, we ensure regulatory compliance of your quality management system.  
Person Responsible for Regulatory Compliance (PRRC)  
We take on the role of the Person Responsible for Regulatory Compliance (PRRC) according to MDR and IVDR and ensure your regulatory compliance.  
Results 161 until 170 out of 1352
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