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AI/ML Compliance
How We Help
We support your team by developing and organizing documentation such as:
- AI/ML feature descriptions aligned to intended use and device claims.
- Dataset summaries that explain provenance, relevance, and limitations.
- Performance and robustness evidence packaged for regulatory review.
- Risk-based narratives addressing failure modes, bias considerations, and controls.
- Traceability linking requirements, risks, tests, and supporting artifacts.
Why It Matters
AI/ML can materially affect device performance and risk. Clear, traceable documentation helps reviewers understand what the model does, how it was evaluated, and how risks are controlled—often reducing follow-up questions during review.
If you’re planning a 510(k) submission or responding to an AI request involving AI/ML, schedule a consultation to discuss your device, timeline, and current artifacts or to find out about AI and machine learning compliance for medical devices.
