SaMD Best Practices Checklist v1.1
Avoid surprises. Build with confidence.
The worst time to find a gap in your process is after development is done. This free 4-page checklist is backed up by 50 pages of details to help you catch what others miss before it becomes a delay, audit finding, or failed submission.
Created by experts in SaMD architecture, regulatory compliance, and product development, this checklist covers every critical checkpoint across the product lifecycle.
What’s inside
75+ detailed checkpoints across design, dev, testing, and post-market
A structured, phase-based checklist aligned to IEC 62304, ISO 13485, ISO 14971, and FDA guidance
One-click summaries of each item, with practical implementation tips and real-world examples
Security and privacy essentials including post-quantum cryptography, SSO, and auditing
Testing strategies for state restoration, performance, crash recovery, and more
Runtime and config readiness: feature flags, licensing, and recovery tools
DevOps and observability benchmarks aligned with industry best practices
Design control and documentation mapped to FDA and EU expectations
Post-market surveillance and labeling preparation built in
Who it’s for
MedTech Product Managers tired of surprises during audits
Regulatory Affairs professionals looking to streamline internal alignment
Software Engineers and Architects building for compliance from Day One
Quality and Clinical leaders seeking visibility into gaps before it’s too late
