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 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…
DetailsThe risk management plan is one of the most important documents in technical documentation. Accordingly, authorities and notified bodies examine this plan intensively. However, it is not only from a regulatory perspective that medical device manufacturers benefit from a precise risk management plan. This article 1. What a risk management plan is In a risk…
DetailsMDCG published guideline MDCG 2023-4 in October 2023 entitled “Medical Device Software (MDSW) – Hardware combinations – Guidance on MDSW intended to work in combination with hardware or hardware components.” Criticism 1: Unclear scope of MDCG 2023-4 The title gives the impression that (all) types of combinations of hardware and Medical Device Software (MDSW) are…
DetailsHow to meet PMCF regulatory requirements as quickly as possible Post-Market Clinical Follow-up is increasingly being criticized by the notified bodies. And this is after the manufacturers have successfully mastered the hurdle before: the initial clinical evaluation. This article provides manufacturers of medical devices with 1. PMCF: The basics a) Objective and definition The MDR…
DetailsBoth the FDA and IEC 62304 recognize software developed by third parties. They refer to Off-the-Shelf Software (OTS) and Software Of Unknown Provenance (SOUP). What is the difference between OTS and SOUP? What do they have in common? What legal requirements do they have to meet? This article provides answers. 1. SOUP and OTS: definition…
DetailsMedical devices are increasingly based on closed-loop systems. “Closed-loop systems” are also mentioned in the Medical Device Regulation (MDR). In this article you will learn what closed-loop systems are, where they are used in medicine, and what regulatory requirements they need to meet. The article also reveals how you can save several hundred euros buying the…
DetailsThe term “predicate device” most often comes up in the context of FDA 510(k) clearances. However, the FDA does not define this term. It does, however, define what “substantial equivalence” is. Sounds complicated? Demonstrating equivalence is by no means only relevant in the FDA context. That’s why this article provides clarity – especially but not…
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