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346 results:
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…  
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Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report)  
Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMS Report) The MDR and IVDR require either a “Post-market surveillance report” or a “Periodic safety update report” from…  
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Latest Articles  
Here you can find our latest articles and the possibility to access our articles via the quick access function.  
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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…  
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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…  
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Digitalization of notified bodies  
Digitalization of notified bodies Digitalization of notified bodies will transform the medical device ecosystem over the next few years. This article describes the impact of this…  
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Devices without an intended medical purpose - Annex XVI devices  
Devices without an intended medical purpose - Annex XVI devices The EU Medical Devices Regulation (MDR) regulates not only medical devices, but also devices without an intended medical…  
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Class-1-Software  
Class I software Practical guidance based on the experience of the Johner Institute, Oliver Hilgers and Stefan Bolleininger  The discussion about class I software continues to rage.…  
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Transitional Periods MDR, regulatory requirements  
MDR Transitional Periods In Article 120, the MDR establishes its transitional provisions, including the transitional periods. However, the descriptions of these transitional provisions and…  
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