HoldFieldMedical Device
Quality gets traceable proof for every unit — not screenshots.
Signature inspection rule
surface pitOver limit → reject
measured 0.35 mmlimit 0.2 mm
critical region · articulating surfaceReject a surface pit above 0.2 mm in articulating surface → this run sealed REJECT.
Defect families
surface pitscratchcontaminationmolding flaw
Sample part
Machined titanium implant bodyFirst deployment: Final visual / molded-part verificationToday's pain
Manual inspection variationRegulated evidence burdenCAPA investigation timeLot traceability
Evidence need
Full traceable evidence for every unit, retained for audit.
Recommended: surfacecell