HoldFieldMedical Device
Quality gets traceable proof for every unit — not screenshots.
Example part: Machined titanium implant body. Suggested first pilot: Final visual / molded-part verification.
Example workflow tailored to this manufacturing profile. Not a customer claim.Today's pain
- Manual inspection variation
- Regulated evidence burden
- CAPA investigation time
- Lot traceability
Defect families
surface pitscratchcontaminationmolding flaw
Signature inspection rule
Reject a surface pit above 0.2 mm in a critical region (articulating surface).
In this example run the part measured 0.35 mm → REJECT.
Evidence need
Full traceable evidence for every unit, retained for audit.
Recommended demo: surfacecell — Surface defects and evidence depth matter most for this profile.