Quality, FAI and Traceability for Machined Medical Parts
What you receive with every lot, how records trace back to the heat number of the bar, and where the line sits between the shop's job and yours as the device maker.
Documentation package
The documents below are agreed at quote stage, so the price already includes the paperwork your supplier controls need.
| Document | When | What it shows |
|---|---|---|
| First Article Inspection (FAI) report | First lot, and after any change | Every characteristic on a ballooned drawing measured and recorded, with CMM data |
| Mill certificate | Every lot | Chemistry and mechanical properties of the heat, traceable to the bar used |
| Certificate of conformance | Every lot | Part number, revision, lot number, quantity, conformance statement |
| Dimensional inspection report | Every lot | Critical characteristics at the agreed AQL or 100% inspection |
| Process certificates | Every lot with finishing | Passivation per ASTM A967, electropolish, anodize, with subcontractor named |
| PPAP Level 3 package | On request | Process flow, control plan, MSA and capability data, quoted separately |
Traceability
Bar stock is received against its mill certificate and tagged with the heat number. The traveler carries the lot number through every operation, finishing step and inspection, so each shipped part traces back to the heat it came from.
Inspection
CMM, optical comparator and height gauge. GD&T including flatness, profile, runout, concentricity and perpendicularity is verified and reported. Every called-out dimension on a prototype is checked before a second piece runs.
NDA & drawing security
Mutual NDA before any drawing review on request. Files are stored with access control, never shared with shops that are not assigned to your RFQ and never reused for other customers. Non-compete clauses are accepted.
Who is responsible for what
Medical device regulation puts the device maker at the centre. This table is how the work is split on every RFQ.
| Task | Device maker (you) | Machine shop | This service |
|---|---|---|---|
| Design, drawing, tolerances | Owns | DFM feedback | Reviews and relays DFM notes |
| Device classification and regulatory submissions (FDA, EU MDR, PMDA) | Owns | None | None |
| Biocompatibility, cleaning and sterilization validation | Owns | Follows your specified process controls | None |
| Supplier approval and quality agreement | Owns | Signs and complies | Coordinates, arranges audits |
| Machining, inspection, lot records | Approves FAI | Owns | Checks the package before shipment |
| Change notification | Assesses under your change control | Notifies before any change | Relays and follows up |
Background reading: ISO 13485:2016 and the FDA quality management system regulation, 21 CFR Part 820.
Quality questions
Is there a cleanroom or certified QMS behind this service?
No cleanroom, FDA registration or ISO 13485 certificate is claimed on this site. If your supplier controls need a certified shop, state it in the RFQ and we only propose shops whose certificate you can verify with the registrar. Final cleaning and packaging to a validated process is normally done by the device maker or its validated contractor.
Can I audit the shop that makes my parts?
Yes. Customer audits of the matched shop are welcomed, on site or remote. We arrange the visit and act as the point of contact before and after.
What is in the documentation package with each shipment?
At minimum: certificate of conformance, mill certificates traceable to heat number, dimensional inspection report at the agreed AQL or 100% level, and process certificates for passivation or other finishing. The FAI report comes with the first lot and after any change. PPAP Level 3 is available on request and quoted separately.
How are changes to a validated process handled?
Once you approve the FAI the process is locked: machine, program, fixture, tooling approach, material source and subcontractors. Any change is notified to you in writing before it happens, so you can assess it under your own change control.
Send your drawing, get a response within 24 business hours
Upload STEP, PDF or DWG. Mutual NDA before review on request. We reply with matched shop options, itemized pricing, lead time and DFM notes.
First response within 24 business hours. No phone calls, everything in writing.