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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EU Authorized Representative (EU-REP) for Medical Devices

Legal Requirements and Practical Implementation under MDR/IVDR EU Authorized Representatives are not only subject to the legal requirements of the MDR and IVDR. They are also liable for violations of medical device law. This expert article provides practical answers to all regulatory questions relating to the EU-REP with specific recommendations for action from the leading consulting firm for…

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IEC 61010-1 and IEC 61010-2-101: Requirements for IVD medical devices

The IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…

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Electronic instructions for use for medical devices

EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. It was revised by Implementing Regulation (EU) 2025/1234. A consolidated version is also available now. We have summarized the requirements for electronic instructions for use for you.

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