Discover new articles every week on the topics of regulatory affairs (including international approval and FDA approval), QM systems (e.g., ISO 13485), risk management (ISO 14971), software development (IEC 62304), IT security, clinical evaluation, usability engineering (IEC 62366-1), and systems engineering (including IEC 60601-1, ISO 10993) - also for IVD medical devices.
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The 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.
DetailsManufacturers 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.
DetailsIn 21 CFR part 820, the FDA formulates the requirements for the quality management systems of medical device manufacturers, among others. Thus, 21 CFR part 820 (Quality System Regulation QSR) is or was the counterpart to ISO 13485.
The EU plans to replace the existing Directive 2006/66/EC with the new EU Regulation on batteries and waste batteries (“Battery Regulation”). This article clarifies,
DetailsUniversity institutions in particular regularly publish medical software as open source. This raises doubts as to whether this open-source software counts as a medical device and what regulatory and (product) liability risks are involved. This article provides a quick overview.
DetailsCombination products consist of the combination of a medical device and a medicinal product. Since both medical device and medicinal product law could be applicable here, there are some special features that must be taken into account for products of this type. In this article, you learn more about
DetailsIs there a duty for medical device manufacturers for validating ChatGPT and other LLMs that they use in the development, production, approval, and monitoring of their products? If so, how can this be achieved with models that deliver non-deterministic results? This technical article provides answers to these questions and to the question of what your…
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