医疗器械质量套件

Medical device design record (DHF)

Nonconformity and CAPA record: description, containment, root cause, similar nonconformities check, actions, effectiveness, closure; ISO 13485 and QMSR notes

Medical device risk management file: plan with acceptability criteria, safety characteristics, hazards, controls, overall residual risk, review, post-production loop

IEC 62366-1 usability file: use specification, known use problems, hazard-related use scenarios, formative and summative evaluation, root causes

STRIDE threat model: scope, DFD with trust boundaries, assets, threats per element, L x I rating, mitigations, risk acceptance

IEC 62304 software file: safety class, development plan, requirements, architecture, SOUP list, testing, release, maintenance, problem resolution

Risk-based CSV/CSA plan: intended use, GxP assessment, software category, risk scoring, supplier assessment, URS, testing, ALCOA+, Annex 11 and Part 11 mapping

V&V plan: integrity level scheme, tasks per life-cycle phase, minimum tasks by level, independence, anomalies, reporting, schedule

EU MDR technical file index: classification, Annex II sections 1 to 6, GSPR checklist, V&V and clinical data, Annex III PMS plan and PSUR