Computerized Systems Validation CSV

We frequently get asked, “Do you also offer Computerized Systems Validation?” One of the reasons for the interest is certainly: Authorities and notified bodies increasingly address the Computerized Systems Validation (CSV) in audits. This article introduces regulatory requirements regarding “Computerized Systems Validation” and provides guidance on how you can best meet these requirements.

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In vitro diagnostic medical device performance evaluation: 8 steps to conformity

If manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process: They are risking patient safety. Therefore, the IVDR sets strict requirements for this performance evaluation. Find out how the requirements of the IVDR for the performance…

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Cytotoxicity testing according to EN ISO 10993-5: Avoiding pitfalls when choosing a laboratory

Cytotoxicity 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…

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Avoid the five most common mistakes when submitting a Premarket Notification (510(k))

The 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…

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Post-Market Surveillance and monitoring of devices on the market

Post-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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MDCG 2020-6: Clinical data requirements for legacy devices

Currently, manufacturers of legacy devices can keep their devices on the market without demonstrating conformity under Regulation 2017/745 on Medical Devices (MDR). However, manufacturers will have to provide the necessary clinical data by the end of the transition period at the latest. The requirements for clinical data that can be used to demonstrate conformity have increased enormously under the MDR. Furthermore,…

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