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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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. 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,…
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…
DetailsThe third edition of ISO 14971 has been available since December 2019. This new version of ISO 14971 was published as ISO 14971:2019. It is an evolutionary development of ISO 14971:2007 and does not break with previous concepts. Manufacturers should familiarize themselves with the new and amended requirements of this standard. In December 2019, the…
DetailsIf manufacturers don’t conduct a legally compliant performance evaluation of their in vitro diagnostic medical device (IVD), they aren’t just running the risk of problems during the authorization process: They are risking patient safety. Therefore, the IVDR sets strict requirements for this performance evaluation. Find out how the requirements of the IVDR for the performance…
DetailsThreat modeling is a “mandatory” topic for all manufacturers of medical devices that contain or are software. This is because threat modeling is a structured process for the systematic analysis of IT security risks that auditors consider to be the “state of the art.” 1. Why should you use threat modeling? Reason 1: To develop secure devices…
DetailsIf a medical device does not (or no longer) meets the FDA’s requirements, manufacturers, distributors, and importers must recall it. This applies in particular if the device presents a hazard. In this article you will learn, 1. What is a recall? 1.1 The FDA’s definition of the term recall A recall is a way for…
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