[sergers]

For diagnostic imaging (x-rays, CTs etc) which we make software for, alot of equipment is FDA regulated.

We chose to go for class 2 designation in FDA terms as it shows you comply with uptmost regulations, which is a selling point. Some hospitals depending on state gets rebates for meeting compliance.

It depends on what space you are going into. If it touches a patient, more than likely FDA regulated in the USA.

Other countries have similar orgs ( Canada has... Health Canada).

We also work with DoD/VA... Don't get me started on compliance with them.(the security stuff is a plus though, while initially challenging to meet, it has us pushing the code into commercial space products, everyone benefits from the extra security hardening. )