Policy Details

Good Machine Learning Practice for Medical Device Development

Summary

Tri‑agency principles for machine learning‑enabled medical devices covering good practices across the total product lifecycle (data, training, testing, deployment, and ongoing learning) to promote safety, effectiveness, and quality.

Healthcare Implications

Device developers and clinical collaborators can use the principles as scaffolding for validation, change management, and transparency – especially for continuously learning models.

Impact Level

Medium

Keywords

Clinical Quality & Efficacy

Stakeholders

Providers & Health Systems; Regulators & Government