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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We have known how vulnerable IT security is in the healthcare sector since February 2016, when the IT infrastructures of many clinics were brought to a standstill by a simple virus attack. As a result, the authorities are paying closer attention to ensuring that not only clinics but also manufacturers guarantee the IT security of…
DetailsThe regulations relevant to usability engineering require formative evaluations.
The MDR and IVDR require either a “Post-Market Surveillance Report” or a “Periodic Safety Update Report” from medical device manufacturers. The Periodic Safety Update Report is abbreviated as “PSUR”, the Post-Market Surveillance reports as “PMS report”.
DetailsThe MDR requires medical device manufacturers to conduct Post-Market Surveillance (PMS) and thus collect PMS data. This article is intended to help clarify the regulatory requirements manufacturers must consider when collecting these PMS data. Notably, it is intended to highlight whether manufacturers need to consult an ethics committee in Europe if the data arise from…
DetailsBoth IEC 62304 and the FDA require integration tests.
The digital transformation of notified bodies will transform the medical device ecosystem over the next few years. This article describes
Practical 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.
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…
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