White Paper

SaMD Regulatory Requirements

Learn which essential regulations and standards are necessary to meet compliance for SaMD and other medical device software.

List and descriptions of each essential SaMD regulations
Easy reference 21 CFR Part 820 review
What to do with this compliance information?

Get the

White Paper

More resources

Discover Why Traceability Doesn't Have to Be So Hard

Explore why traceability has traditionally been so challenging in medical software development and why cloud and AI only add to the complexity.

Regulatory Pathways

Learn about the different approval pathways possible, and how to find the one that works best for you.