Commit to a Traceability Map
Commit to building a traceability map for one medical-device feature.
Build one mini traceability map for a medical-device feature before the next review. Use a real feature such as an alarm, app prompt, sensor reading, sterile-barrier step, dose display, cybersecurity update, or IFU warning. Feature: __. User need: __. Risk/harm: __. Design input: __. Design output: __. Verification: __. Validation or use evidence: __. Labeling or postmarket signal: __. In three days, check whether the row was drafted and used in a review or shared with a quality/regulatory partner. A design review where an alarm, alert, or dose-display feature needs evidence beyond verbal explanation. A risk review where a hazard…
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