The process FMEA (pFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes, such as device production and cleaning. Laws, such as the MDR, and standards, such as ISO 13485, require medical device manufacturers to identify and control such process risks. 1. What the pFMEA is a) The pFMEA is a…
DetailsCytotoxicity testing can be used to test a sample to determine how much it can damage, or even cause the death of, human cells. Standards and legislation require manufacturers to demonstrate that their devices are not cytotoxic. With a good test setup, it is possible to detect whether a sample is 100% cytotoxic, i.e., highly cytotoxic, or…
DetailsThe 510(k), also known as “Premarket Notification”, is one of the most common procedures for the authorization of medical devices in the USA. The concept is based on demonstrating equivalence with a predicate device (equivalent device). But the same mistakes, which can result in the entire 510(k) authorization failing, are made time and again. It…
DetailsPost-Market Surveillance (PMS) is a proactive and systematic process to derive necessary corrective and preventive actions (CAPA) from information about medical devices already placed on the market. We have created a Post-Market Surveillance checklist for you. With this checklist, you can find out whether you meet the regulatory requirements of the MDR for Post-Market Surveillance…
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