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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1. Documentation Level: End of Level of Concern On June 14, 2023, the FDA released the guidance document Content of Premarket Submissions for Device Software Functions. This document replaces the guidance document introducing the Level of Concern and only distinguishes between two classes. a) Determination of the classes The FDA no longer defines three “Level…
DetailsSoftware maintenance is the phase in which software is further developed, e.g., with the objective of According to the FDA, 79% of all bugs occur during software maintenance. Accordingly, some regulations address this topic. Regulatory requirements for software maintenance Requirements of the Medical Device Regulation MDR (2017/745) The Medical Device Regulation requires medical device manufacturers…
DetailsCompanion Diagnostics (also known as CDx) are used together with a medicinal product. Physicians use them, for example, to make sure that a particular medicinal product is actually suitable for a patient. This means that CDx play a particularly important role in personalized medicine. As the Companion Diagnostic and the medicinal product are inseparably linked,…
DetailsPhantoms in medical technology help to develop, validate, “approve” and monitor medical devices in the markets faster and more effectively. This article describes which organizations particularly benefit from the use of these phantoms and what requirements they must meet. 1. Examples of phantoms in medical technology Anthropomorphic phantoms are replicas of bodies that behave like…
DetailsUnderstandably, laws and standards also require IT security for legacy devices. However, the way in which these requirements are formulated often leads to confusion. For example, legislators and standard committees have been unable to agree on common definitions. One definition refers to the IT security of legacy devices, another to the IT security of old…
DetailsLegislators are continually changing the regulatory framework for medical devices, as we have seen in Europe with EU Regulation 2017/745 (MDR) and EU Regulation 2017/746 (IVDR). This then raises the question of how to deal with legacy devices. These are the medical devices that manufacturers have legally placed on the market under the old directives…
DetailsThe EU regulations place high requirements on the so-called placing on the market of medical devices. Find out in this article what these regulations mean by placing on the market, what misunderstandings and contradictions you must be aware of, and what requirements manufacturers and devices must meet. 1. Placing on the market: Basics a) Definition…
DetailsThe digitalization of the production is an essential part of the digital transformation of manufacturing companies. However, not all companies benefit to the same extent from digitalization. This article describes, 1. What is the digitalization of the production? The digitalization of the production covers two areas: 2. Why is the digitalization of the production important?…
DetailsSoftware as Medical Device (SaMD) refers to (independent) standalone software that is a medical device but not part of one. It should not be confused with Medical Device Software as defined by the EU. As a manufacturer, when do you have to qualify Software as Medical Device, and when as Medical Device Software? Find out…
DetailsDefining the regulatory strategy is one of the central tasks of the regulatory affairs departments at medical device manufacturers. Why is a good regulatory strategy so important? What do regulatory affairs experts need to do? This article provides the answers. 1. What does a regulatory strategy determine? a) Background Manufacturers of medical devices must comply…
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