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 MDR and IVDR use the terms device category and generic device group without fully defining them. ISO 13485:2016 introduces the medical device family. Finally, the MDCG uses the term device range. The definitions of these terms determine the allocation of UDIs and the sampling of product files during certification. Therefore, it is important for…
DetailsLaws such as the Federal Data Protection Act and the Criminal Code make it unmistakably clear that data protection is particularly important in the case of medical data. In this article, you can read why medical data requires special protection, what the special features of medical data protection are, and which data protection laws must…
DetailsThe authorization of medical devices in Japan is a big challenge for European manufacturers. But it’s not one they should shy away from, because Japan is one of the 10 biggest markets in the world. This article will tell you about the requirements you have to meet and the best way to overcome the hurdles.
DetailsMore and more manufacturers are using machine learning libraries, such as scikit-learn, Tensorflow, and Keras, in their devices as a way to accelerate their research and development projects. However, not all manufacturers are fully aware of the regulatory requirements that they have to demonstrate compliance with when using machine learning libraries or how best to…
DetailsThe CFDA, the China Food and Drug Administration, was replaced on September 1, 2018 by the National Medical Products Administration (NMPA), which reports to the Chinese Ministry of Health. This article will provide you with further information on the work and responsibilities of the CFDA/NMPA and the approval of medical devices in China. You will…
DetailsWith its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations. In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and…
DetailsAbbreviated 510(k) is one of three 510(k) clearance procedures offered by the FDA. This article tells you,
DetailsIn a guidance document, the FDA explains how to implement a software change in a regulatory-compliant manner. It describes when you need a new 510(k) submission (Premarket Notification) and when you “only” need to document the changes.
DetailsWhat a lot of people understand by accessories is different from the definition of the term in the German Medical Device Act (MPG). This article gives you an overview of the definition of the term, the regulatory requirements, and typical questions.
Details1. Definition of the term UOUP (according to IEC 62366) The IEC 62366-1:2015 (the standard for “Application of usability engineering to medical devices”) introduces the term UOUP and defines it as follows: A UOUP (User interface of unknown provenance) is a user interface or parts of a user interface with an unknown development process for…
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