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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Brexit 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!
DetailsISO 19011 is the international guideline for auditing management systems. Therefore, your notified body considers ISO 19011 state-of-the-art when it checks during your ISO 13485 certification audit whether you are conducting your internal and supplier audits effectively. Consequently, those responsible for quality management, in particular, should be familiar with and consider ISO 19011. This article…
DetailsWhat are primary users? What are secondary and even tertiary users? What specific requirements do regulations place on these user types, particularly the FDA and IEC 62366? Should we talk about users, operators, or consumers? This article provides answers.
FMEA, or Failure Mode and Effect Analysis, is a procedure for investigating the unknown effects of known causes. In the case of medical devices, for example, FMEA is used in risk analysis to analyze the consequences of a faulty component, in particular, the resulting hazards.
DetailsThe process FMEA (pFMEA) is a method for the systematic analysis of risks resulting from failure modes in processes, such as device production and cleaning. Laws, such as the MDR, and standards, such as ISO 13485, require medical device manufacturers to identify and control such process risks.
DetailsMany companies confuse “user experience” with “usability,” which leads to confusion not only during audits. This article distinguishes between the two terms and reveals how you can test both.
Regulations such as MDR and ISO 13485 require manufacturers to define quality objectives and a quality policy. These are prerequisites for the conformity of the QM system and thus for obtaining the associated certificate.
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