The 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…
DetailsThe qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays. 1. Definition of terms 1.1 Qualification Qualification is…
DetailsMore and more medical devices are using artificial intelligence to diagnose patients more precisely and to treat them more effectively. Although a lot of devices have already been approved (e.g., by the FDA), a lot of regulatory questions remain unanswered. With the AI Act, the EU has published a regulatory framework for AI, and not…
DetailsThe Medical Device Regulation (MDR) (like the Medical Device Directive (MDD) and thus the Medical Device Act before it) requires manufacturers to comply with life cycle processes for their software. IEC 62304 and IEC 82304 also refer to software life cycle processes. But what is a software life cycle? The software life cycle includes all…
DetailsIEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.” IEC 82304: Why another standard? Closing the IEC 62304 validation gap IEC 62304 was launched with the claim of being applicable to all medical device software – whether standalone or embedded. However, the…
DetailsThe software architecture documentation primarily serves these objectives: Fast, effective, and plannable software development will succeed if the task (to develop software that meets the software requirements) is broken down into solvable subtasks, which can be distributed among many developers. The prerequisite for this is a precise (documentation of the) software architecture, which is unfortunately…
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