Medical Device

Nothing in a device file is casual writing. Every design input, hazard note and complaint summary can be pulled into an audit years later. Teams still want an assistant for the first draft. This starter governs the traffic around that draft. It is a control layer and not a claim about the device itself.

Device teams write a lot of controlled text. Design inputs, risk files, complaint summaries and labeling drafts all carry traceability duties under a quality management system. An assistant can speed that drafting. It must not become an undocumented author of a design decision.

Order on the request side is deliberate. Injection screening leads, so an instruction hidden in a pasted complaint cannot switch off the checks behind it. Identity enforcement follows and turns away an unauthenticated caller. Health record matching then supplements the general identifier stage, and masking hides patient, member and policy numbers found in complaint text.

Returned text meets two gates. Citation checking measures grounding against the context you supply and marks a weak reference without stopping delivery. Quality scoring is the harder one. The aggregate floor is 0.88, built from equal parts relevance and accuracy, with component floors of 0.78 and 0.80. Output under 120 characters or a single sentence fails on length alone.

This starter is a governance aid and nothing more. It makes no statement about device classification, clearance or clinical validity, and it cannot make one. History capture holds metadata only, so no design text sits inside that record. Policy marking never blocks a request and never creates a records repository. Your quality system still owns document control, approval and traceability.