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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Manufacturers of (most) class III medical devices have to undergo the Premarket Approval (PMA) procedure. That is one of the FDA’s most complex submission pathways, with a typical processing time of more than one year. The FDA usually approves only a few dozen PMA applications per year. This article presents the FDA’s requirements and tips…
DetailsWith the UDI system, the EU has introduced an obligation to identify and register medical devices that goes far beyond what is still required under the MDD. The Medical Device Regulation (MDR) even requires a UDI for standalone software. Read about what you need to prepare for here.
DetailsThis article tells you which regulatory requirements you must fulfill, how a vigilance system differs from a system for post-market surveillance, and how you can set up and operate a vigilance system quickly and in compliance with the law.
Manufacturers who wish to place medical devices on the market in the EU must comply with the European Medical Device Regulation MDR. This Regulation (EU) 2017/745 on Medical Devices, as it is officially titled, also imposes requirements on notified bodies, distributors, importers, and health institutions such as hospitals.
DetailsIn this article you will learn,
The DAkkS, the German Accreditation Body, is Germany’s national accreditation authority.
A declaration of interest is a formal document designed to make potential conflicts of interest transparent. Individuals submit a declaration of interest to demonstrate their objectivity and independence. This article is about declarations of interest in a clinical context.
DetailsInternal audits are inspections of the quality management system (QM system) and its processes by the organization itself. This is why they are also called 1st party audits. ISO 13485 requires internal audits like its “sister standard,” ISO 9001, and other standards and regulations. Therefore, internal audits are also a subject of external audits and…
DetailsThe incorporation of AI in medical devices has made great strides, for example, in the diagnosis of disease. Manufacturers of devices with machine learning face the challenge of having to demonstrate compliance of their devices with the regulations. Even if you know the law – what are the standards and best practices to consider in…
DetailsMore and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
