Many designers are aware of the guidelines and requirements outlined by the FDA.
The FDA's validation of medical device software is done for any of these, which the FDA considers as software: The FDA spells out the major areas in which it carries out medical device software validation.
It lists out the elements related to a medical device for which medical device software validation has to be done.
In the end, the FDA makes the last call for a US based device- is the product safe for the public.
It is your job as the device maker to prove to the FDA that you have performed due diligence to ensure product safety and quality.
A good place to start your learning process is to reference your government and local resources.
In the US, you should reference the US Department of Health and Human Services web site for the Food and Drug Administration (FDA).
Specifically, begin by reading the Device Advice: Device Regulation and Guidance documentation.
The second step is to reference local and regional organizations that train or offer educational forums.
In particular, there is Sec 4 of this guideline, which relates to medical device software validation.
Medical device development is a complex process with quality serving as the highest concern.
Our customers span large established companies to small university based research teams.