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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Practical guidance based on the experience of the Johner Institute, Oliver Hilgers, and Stefan Bolleininger The discussion about class I software continues to rage. This article provides guidance regarding the MDR rules for the classification of medical software.
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…
DetailsQM certification refers to the certification of a quality management system (QM system or QMS) by a certification body. The certification confirms to the certified company that its QM system meets a standard (e.g., ISO 9001, ISO 13485) or a law (e.g., MDR, IVDR).
EN ISO 14155:2020 is a standard that has not yet been harmonized for the MDR. It is titled “Clinical investigations of medical devices for human subjects – good clinical practice.” It describes the state of the art for medical device manufacturers in preparing, planning, conducting, and evaluating clinical investigations. It also determines the responsibilities of…
DetailsThe MDR contains the Classification Rule 11. This rule is especially for software. The Rule 11 has serious implications: it bears the potential to further undermine Europe’s innovation capacity. Manufacturers should familiarize themselves with the MDCG‘s interpretation to avoid misclassifying software and to be able to follow the reasoning of notified bodies and authorities. This article…
DetailsBrexit was completed in January 2021. What was a cause for celebration for some means an additional burden for many – including medical device manufacturers. For manufacturers, it is important to understand which regulatory requirements they will have to fulfill and which transition periods they will benefit from if they want to continue selling their…
DetailsThe Global Medical Devices Nomenclature (GMDN), the Universal Medical Device Nomenclature System (UMDNS), and the Classificazione Nazionale dei Dispositivi Medici (CND) are nomenclatures for medical devices. The latter serves the EU as the basis for the European Medical Device Nomenclature (EMDN). Finally, there are the MDA/MDN codes in accordance with the EU Implementing Regulation (EU)…
DetailsThe IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…
DetailsRegulatory affairs managers take care of the approval of medical devices. In this article, you will learn, Update: Impact of the digital transformation on the tasks of regulatory affairs managers added!
DetailsIn this article, you will learn about the requirements that the FDA places on human factors engineering (HFE), the products to which the FDA applies these requirements, and how you can implement these requirements.
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