Manufacturers who use machine learning (ML) in their medical devices or IVDs must comply with numerous regulatory requirements. This article provides an overview of the most important regulations and best practices for implementation. It saves you the trouble of researching and reading hundreds of pages and helps you prepare perfectly for your next audit.
DetailsThe MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsOn December 16, 2025, the European Commission published its proposal for revising the MDR and IVDR , already titled MDR 2.0 and IVDR 2.0 respectively. But will manufacturers really benefit from it? This article provides the answers.
The NIS-2 (Network and Information Security) Directive is a European directive (Directive (EU) 2022/2555) that sets minimum standards for cybersecurity within the EU. Does this directive also affect IVD and medical device manufacturers? If so, what does it require, and what should manufacturers do? This article provides answers.
DetailsWe 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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