Artificial intelligence in medicine
More and more medical devices are using artificial intelligence e.g., to diagnose patients more precisely and to treat them more effectively.
Qualification and classification of IVD software
The 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.
DetailsSoftware life cycle: What is meant by this?
The 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?
IVD software manufacturers take note
This article describes the requirements of the in vitro diagnostic medical device regulation (IVDR) for software development and documentation. The requirements apply to software that is part of an IVD (embedded software) and to software that is an IVD itself (“standalone” software). This article also compares the software requirements of the MDR and the IVDR.
DetailsIEC 82304 – What the standard requires of “health software”
IEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.”
Software architecture documentation
The 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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