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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When ANVISA registration is no longer sufficient As a manufacturer, there are some hurdles you have to overcome before selling your medical device in Brazil. The best known is registration with ANVISA. In addition to this, you may also need INMETRO or ANATEL certification for your device. Manufacturers should be aware of the cases in which they must…
DetailsIf you have to conduct a clinical investigation for your medical device or clinical performance study for your IVD, you won’t be able to avoid sample size planning. And you will need to avoid the following two problems when calculating the sample size: Therefore, you need to accurately identify the exact sample size needed so…
DetailsThe same legal requirements apply to the clinical evaluation of software as to the clinical evaluation of all medical devices. This means that as a Medical Device Software (MDSW) manufacturer, you must prepare a clinical evaluation for your product just like any other manufacturer. A performance evaluation must be carried out for software that is an in vitro diagnostic…
DetailsA lot of medical device manufacturers see the international authorization of their device as a potential hazard: the opportunities offered by new markets are offset by hard-to-calculate risks as well as the time and costs required for these authorizations. The five steps presented in this article will help manufacturers to manage these risks better. And this is…
DetailsA Quality Assurance Agreement (QAA) is a contract between companies such as medical device manufacturers and their suppliers (subcontractors). In these contracts, both parties regulate which obligations the suppliers must fulfill regarding the quality of the devices and services supplied. Find out in this article what content a Quality Assurance Agreement should contain and when…
DetailsThe literature search is a key part of the clinical evaluation. It usually involves numerous hours of work. This article will give you six tips to help you efficiently carry out and fully document the literature search. In the literature search, manufacturers gather together scientific articles, among other reasons, to document the state of the…
DetailsISO 13485 requires a medical device file for each medical device type or medical device family. Many manufacturers think that the medical device file is the same as the technical documentation required by the MDR or IVDR. But that isn’t entirely true. Does one of the three files required by the FDA (DMR, DHF, DHR) match the…
DetailsWith the Post-Market Surveillance plan (PMS plan), manufacturers are trying to achieve two (potentially) contradictory goals. On the one hand, they have to comply with the legal requirements and maximize the safety of their devices. And on the other, they can only take on as much work as they can realistically do in the long…
DetailsThe 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…
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.
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