IEC 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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