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 risk acceptance matrix, also known as the risk assessment matrix, is a proven tool that (medical device) manufacturers use to express their (product-specific) criteria for risk acceptance. Notified bodies often check the risk acceptance matrix first and especially intensively when assessing the conformity of the technical documentation with the statutory requirements. This article helps…
DetailsMedical devices must comply with the legal requirements for functional safety. Unfortunately, the relevant standards and laws for medical devices do not define or use the term “functional safety.” This article provides clarity.
DetailsThe probability of software defects is difficult to estimate. It’s so difficult that the “old” DIN EN IEC 62304:2006 wrote: “However, there is no agreement on how to determine the probability of the occurrence of software failures using traditional statistical methods.” The standard concluded that “the probability of such a malfunction must be assumed to…
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA recognizes critical (user) tasks. In development, use cases and user stories are used. This variety of terms makes it difficult to achieve a common understanding. However, this is necessary to create a consistent and legally compliant usability engineering file and avoid regulatory problems. This…
DetailsIEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA uses the concept of critical (user) tasks. In development, one works with use cases and user stories. This diversity of terms makes a common understanding difficult. However, this is necessary to create consistent and legally compliant usability files and to avoid regulatory problems. This…
DetailsThe cybersecurity standard IEC 81001-5-1 focuses on how IT security needs to be taken into account in the software life cycle. As a special standard for health software, it supplements IEC 82304-1 and IEC 62304 among others, and can close gaps that urgently need to be closed. The EU is currently planning to harmonize IEC…
DetailsLaws and standards require organizations to prepare a risk management report. Notified bodies and authorities examine these reports intensively because risk management is a key regulatory requirement. Therefore, it is important (not only) for manufacturers to prepare precise, complete, and correct risk management reports. This article provides assistance in this regard.
DetailsSpecial authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…
DetailsBoth the MDR and IVDR introduce the concept of Common Specifications.
In May 2016, the German version of IEC 60601-1-2:2014 (Edition 4) was published as DIN EN 60601-1-2:2016 with the title “Electromagnetic disturbances – Requirements and tests.” At the end of 2020, a new version of this “EMC standard” – modified by Amendment 1 and called Edition 4.1 – was published.
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