IVD medical device software development and regulations

IVD medical device software development and regulations

Software development is a crucial part of product development for IVD medical devices, and, in recent years, it is increasingly becoming a differentiator between competitive products. It is essential to build software that enhances medical treatments and patient care while supporting the software users and helping them perform their work tasks simultaneously. But first, we need to define the fundamental terminology in regulated environments such as IVD medical devices. Definitions Medical device If a device is used to diagnose, care for, treat or prevent a...

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