FDA regulates the healthcare industry in The USA.
You need to validate your medical software if you fall under any of these categories:
1. Companies Dealing in Pharma and Botanicals.
2. Surgical Instrument Makers
3. Medical Device Manufacturers
But the question that arises here is how to validate your medical device software.
Here are the five simple steps you need to follow and it's done!
https://bit.ly/3UfdvMa