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 must demonstrate compliance with the MDR requirements for usability for all medical devices without exception. Transition periods apply to some products. However, manufacturers are well advised to familiarize themselves right away with the differences between the MDD and MDR requirements for usability. This is the only way to smoothly manage the transition to the…
DetailsISO/TS 24971-2:2026 specifies for the first time how manufacturers should apply ISO 14971 to machine learning components in AI-based medical devices and IVDs.Although this Technical Specification is not directly binding, it is likely to quickly become an important reference for manufacturers, Notified Bodies, and regulatory authorities.This article explains what the standard requires, how it is…
DetailsFor years, the standards committee has been striving to revise the first edition of IEC 62304, which dates back to 2005 – a time before the iPhone. Consequently, there are growing doubts as to whether the standard still reflects the state of the art. This article provides information on the current status and objectives of…
DetailsRobots in medicine—it’s not just about Da Vinci surgical systems. The spectrum ranges from handheld drills with optical tracking to laboratory automation systems and exoskeletons for rehabilitation. This is a hot topic right now: Key patents are expiring, opening the market to new providers. At the same time, AI technologies are enabling entirely new product…
DetailsThe protection classes in accordance with IEC 60601-1 specify the protective measures that manufacturers of medical electrical equipment must implement.
Medical Device Safety Representative: this role is required under the Medical Devices Act; however, since May 2021, this has only applied to manufacturers of in vitro diagnostic (IVD) devices, and no longer to manufacturers of medical devices.
Hospital information systems (HIS) are a type of clinical information system. They are a central component of a hospital’s IT infrastructure. They help digitally manage and process administrative and medical patient data within a hospital. An HIS functions as an electronic patient record and manages processes ranging from admission, through diagnosis and treatment, to discharge…
DetailsArtificial intelligence is becoming part of everyday working life – often faster than companies can react. An AI policy provides the framework for the secure, compliant and efficient use of AI systems. However, many AI policies fall short because they address the wrong problem. This article outlines the key components.
Decision Support Systems are also increasingly being used in medicine. If they are medical devices, they must meet the legal requirements (e.g., the general safety and performance requirements). The hype surrounding Artificial Intelligence, in particular Machine Learning, and users such as Watson are raising hopes for the performance of Decision Support Systems. This article presents…
DetailsOne assumption persists: Products for general laboratory use such as PCR cyclers, NGS devices, fragment analyzers, centrifuges, pipetting robots, and extraction kits must bear a CE-IVD marking. Is this correct? There is often a lack of clarity about Hence, there are uncertainties, in order not to make themselves liable to prosecution. This article provides clarity…
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