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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Both IEC 62304 and the FDA require integration tests. 1. What are integration tests? Integration tests verify whether software components that use interfaces of other components, i. e. call its methods, properly handle their returns (return values, exceptions). 2. Why are integration tests necessary? a) Improve the quality of the software Integration tests, like all…
DetailsThe digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes 1. Drivers of the digital transformation of notified bodies The period in which notified bodies, as an oligopoly, were allowed to pick and choose customers and determine prices and conditions is coming to an end.…
DetailsPractical guidance based on the experience of the Johner Institute, Oliver Hilgers, and Stefan Bolleininger The discussion about class I software continues to rage. This article provides guidance regarding the MDR rules for the classification of medical software. 1. Background a) Relevance of the issue Whether or not medical software counts as class I software is…
DetailsThe Medical Device Coordination Group (MDCG) is an expert panel required by the MDR and IVDR. The MDCG is sometimes confused with another coordination group or with expert panels. You can find out how these groups are differentiated here. Read this article to find out how you are affected by the output of the MDCG’s…
DetailsRegulators still publish laws and regulations as texts. Just as it has been for thousands of years. Regulation as Code represents a radical paradigm shift away from this practice. Is it possible to transform laws into algorithms? Why should anyone want to do this? How should you get ready for this as a regulator, manufacturer, authority, or…
DetailsDecision Support Systems are also increasingly being used in medicine. If they are medical devices, they must meet the legal requirements (e.g., the general safety and performance requirements). The hype surrounding Artificial Intelligence, in particular Machine Learning, and users such as Watson are raising hopes for the performance of Decision Support Systems. This article presents…
DetailsFrom 2017-2022 the FDA offered a “Precertification (Pre-Cert) Pilot Program” to specific companies for standalone software to simplify and accelerate the approval process for digital health devices. This article summarizes the most important aspects and provides a quick overview. Precertification (Pre-Cert) Pilot Program The FDA has recognized that software The new approach The agency is,…
DetailsThe requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here. 1. Clinical investigations of medical devices a) Definition and objectives According to the MDR, a clinical investigation is During clinical…
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. Computerized Systems…
DetailsISO 15223-1 or ISO 980 The two standards, ISO 980 and ISO 15223-1, regulate the symbols that manufacturers are permitted to use for labeling medical devices. In November 2017, the EU Commission harmonized ISO 15223-1 and added it to the list of harmonized standards. It thus replaces ISO 980 as the standard. The discussion of…
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