Flowcharts showing which software products are regulated as a medical device, and those that are not.
Contents
- How do I know if my software is a medical device?
- What if I need more information?
- Is my software regulated?
- Is its purpose likely to be medical?
- Is it excluded?
- Is the clinical decision support software exempt?
Supporting documents
Is my software regulated?
[PDF, 84.94 KB]