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RegOps – agile development of medical software

The development of a medical device or software is regulated in Europe by the Medical Device Regulation (EU 2017/745). Then again, MDR does not really involve much extra work to software development – compared to what it should be anyway.…


Medical device usability design

Usability is an important part of each and every piece of device and software. When human health is concerned, it is even more crucial. The IEC 62366 standard helps manufacturers ensure that usability is factored into the development process of…