This blog series discusses the Medical Device Regulation (MDR) in brief and how it affects software development for medical devices. In this second part we will discuss the conformity assessment routes, software modules and impact of changes.
Read the first part of the blog series about software qualification and risk classification here.
Checklist for Medical Software Development (2/4)
Considerations on Placing Medical Software on the Market
Impact of Changes
Identifying significant software changes
Impact of changes on qualification or classification
I work as a software developer and quality control manager in the health and wellness technology unit at Pinja. I’m very interested in quality control, and I have over 15 years of experience in tasks related to mobile devices and health tech. In my free time, I exercise by skiing, cycling and going to gym, among other things.
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