Medical-device QMS evidence assembly. No certification, inspection or release authority created.

Device. DEVICE1

Frozen current QMS version. fictional-v1

Baseline. FDA QMSR effective 2026-02-02

Every exact expert-selected instrument requirement. [{"reference":"REQ1","sourceIds":["S1"],"instrument":"FICTIONAL customer-authorized current QMSR requirement","version":"fictional-v1","provision":"FICTIONAL selected current provision","exactRequirement":"FICTIONAL exact controlled-record requirement","selection":"Applicable","selectionRationale":"FICTIONAL qualified applicability rationale","recordIds":["RECORD1"],"reviewIds":["REVIEW1"],"approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-02"}]

Every controlled record. [{"reference":"RECORD1","sourceIds":["S1"],"version":"fictional-v1","requirementReference":"REQ1","qmsVersion":"fictional-v1","kind":"Fictional controlled record","on":"2026-10-03","status":"Current","owner":"Fictional record owner","sha256":"09af1d0212932d147d35388697e14909c29d77332a1caa645e4c7d0cfe8c4609"}]

Every management, internal and supplier audit review. [{"reference":"REVIEW1","sourceIds":["S1"],"requirementReference":"REQ1","qmsVersion":"fictional-v1","kind":"Management review","on":"2026-10-03","position":"Approved","rationale":"FICTIONAL qualified management review","approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-04"}]

Every corrective action and closure support. [{"reference":"ACTION1","sourceIds":["S1"],"requirementReference":"REQ1","reviewReference":"REVIEW1","owner":"Fictional action owner","dueOn":"2026-10-08","status":"Closed","closedOn":"2026-10-04","closureEvidenceIds":["S1"],"closureRationale":"FICTIONAL controlled closure evidence","approvedBy":"Fictional qualified reviewer","approvedOn":"2026-10-04"}]

Unresolved requirement count. 0