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No animal testing to prove biocompatibility  
No animal testing to prove biocompatibility In order to evaluate the biocompatibility of standard materials, medical device manufacturers can, in most cases, avoid animal testing. In recent years  
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7 steps to the DiGA directory  
7 steps to the DiGA directory Since 2020, the German legislature has allowed the reimbursement of Digital Health Applications (DiGA). DiGA manufacturers must fulfill several requirements for this.  
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Software integration tests & integration strategy  
Software integration tests & integration strategy Both IEC 62304 and the FDA require integration tests. 1. What are integration tests? Definition: Integration test In software development,  
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Black box testing  
Black box testing Black box testing is when test cases are derived solely from the specification of the object to be tested (product, component). White box testing, on the other hand, derives the t  
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PMS data: Do you need to involve an ethics committee when collecting data?  
PMS data: Do you need to involve an ethics committee when collecting data? The MDR requires medical device manufacturers to conduct post-market surveillance (PMS) and thus collect PMS data. This ar  
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Market Access  
Approval MDR/IVDR consulting Make an appointment for a free 15-minute strategy discussion, at the end of which we will send you a concrete action plan. After you have given us some basic informati  
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Constance  
City of Constance: The Holiday City We are based in one of the most beautiful places in Germany - the Villa Rheinburg in Constance. It is located right at the point where the Rhine leaves Lak  
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Privacy Shield Agreement: What Its End Means  
Privacy Shield Agreement: What Its End Means On  July 16, 2020, the European Court of Justice declared the Privacy Shield Agreement invalid. The ruling, which is also intended to set limits fo  
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IVDR Readiness  
We perform a mock conformity assessment of your QM system and an exemplary technical documentation. If both are of appropriate quality, we issue an IVDR Readiness Certificate that you can present to  
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What Constitutes the Lifetime of a Medical Device in the EU?  
What Constitutes the Lifetime of a Medical Device in the EU? Operating medical devices beyond the end of their lifetime can be dangerous and legally problematic. Therefore, manufacturers shoul  
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