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 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…
DetailsAuditors and authorities regularly discuss with medical device manufacturers what constitutes the state of the art. These discussions are becoming more intense against the backdrop of the new EU regulations. Manufacturers are facing delays in approvals, unnecessary product redesign, and costly clinical investigations or clinical performance studies for in vitro diagnostic devices (IVDs).
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…
DetailsOne of the most common deviations found during audits is related to the so-called “post-production phase”.
ISO 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…
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.
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