Regulations such as the MDR require proof of the biocompatibility of all materials that come, directly or indirectly, into contact with patients or users. A test-based biocompatibility assessment provides reference data that provides a very good basis in the event of unexpected problems and that helps to quickly and directly identify unknown causes. However, there…
DetailsThe SSCP (Summary of Safety and Clinical Performance) is not the only report that the MDR requires from many medical device manufacturers. In terms of content, the SSCP even overlaps with the PSUR and the PMS reports. The IVDR places almost identical requirements on the SSP (Summary of Safety and Performance). How do all these…
DetailsAQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers. 1. Who is affected by the…
DetailsISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help. 1. Definition of hazard and hazardous situation The ISO 14971 defines: The standard provides examples of hazards (see Fig. 1): The example of “information”…
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