Medical-device and IVD evidence suites

The job

Maintain linked evidence about intended purpose, safety, performance, clinical benefit, state of the art, risk, and post-market experience across the lifecycle.

Writer's control points

• Lock device identity, variant, intended purpose, population, and claims.
• Maintain a reproducible literature method and search update history.
• Separate evidence types and appraisal.
• Connect conclusions to risk management and post-market plans.
• Assess change impact across every linked plan, report, and summary.
• Keep public summaries understandable without weakening risk information.

Dominant risks

Evidence for one configuration or intended use migrates to another; literature searches become irreproducible; old conclusions survive new post-market evidence; and linked documents contradict one another.