AI-Based SaMD Compliance Checklist v1.0

Avoid surprises. Build with confidence.

The worst time to discover a regulatory gap is when your AI-enabled device is already developed or when your submission is under review. This free 4-page checklist is backed up by 50 pages of details to help you catch what others miss, before those issues become show-stoppers, audit findings, or failed regulatory submissions.

Created by experts in SaMD architecture, regulatory compliance, and product development, this checklist was developed from the ground up for AI-based medical software, covering every critical checkpoint from design to post-market.

What’s inside

  • 90+ critical checkpoints for AI SaMD and SiMD

  • Direct mapping to ISO 13485, ISO 14971, IEC 62304, IEC 82304-1, EU AI Act, FDA AI guidance

  • Actionable context for every item

  • Full coverage of AI/ML risks, change control, transparency, and model drift

  • Security, privacy, and dataset versioning requirements

  • Step-by-step AI validation, robustness, and safety checks

  • End-to-end traceability and documentation

  • Post-market monitoring and drift detection

Who it’s for

  • MedTech Product Managers tired of surprises during audits

  • Regulatory and Quality teams building for audits

  • Software Engineers and Architects who want clarity

  • Clinical, Data, and Risk teams closing compliance gaps