# Custom Parts Manufacturing for Medical Devices

> Documented precision in 316L, titanium and PEEK for surgical and device programs.

- HTML page: https://fabvector.com/industries/medical-devices (Portuguese: https://fabvector.com/pt/industries/medical-devices)

## Sourcing pain points we solve

Medical machining is documentation as much as precision: every 316L instrument body and PEEK component must trace back to certified mill stock through a controlled process, and a missing certificate stalls a regulatory submission. Biocompatibility means material substitutions that other industries shrug off are simply not allowed. Patient-contact surfaces routinely call for Ra 0.4 µm with electropolish or passivation per ASTM standards your quality system cites. And device programs iterate under design control, so the supplier has to deliver fast revisions without losing the paper trail.

## Typical parts

- Surgical instrument bodies, tips and handles
- Implant trials and sizing instruments
- Device enclosures and chassis for diagnostic equipment
- Fluidic manifolds for IVD systems
- PEEK radiolucent components

## Recommended materials

- [stainless-steel-316l](https://fabvector.com/md/materials/stainless-steel-316l)
- [titanium-grade-5](https://fabvector.com/md/materials/titanium-grade-5)
- [peek](https://fabvector.com/md/materials/peek)
- [pei-ultem](https://fabvector.com/md/materials/pei-ultem)

## Recommended finishes

- [electropolishing](https://fabvector.com/md/finishes/electropolishing)
- [passivation](https://fabvector.com/md/finishes/passivation)
- [laser-marking](https://fabvector.com/md/finishes/laser-marking)

## Certifications & standards

- **ISO 13485**: We understand ISO 13485 supply chains: controlled processes, full material traceability and certificates of conformance to feed your QMS.
- **FDA 21 CFR 820**: We support purchasing controls under FDA 21 CFR 820 with documented inspection records and lot-level traceability on every shipment.
- **ISO 10993**: We support ISO 10993 biocompatibility files by machining only certified medical-grade stock with mill certs supplied per lot.
- **ANVISA RDC 665**: For Brazil-bound devices, we understand ANVISA good manufacturing practice expectations and provide the supplier documentation your registration requires.

_We understand and support these requirements; certification and documentation scope is confirmed per order — we do not claim to hold certifications on this page._

## Buyer questions, answered

### Which stainless steel should surgical instrument parts be machined from?

316L with electropolishing is the default for corrosion resistance and cleanability; 17-4 PH where a jaw or shaft needs hardness up to 44 HRC; 420/440C for cutting edges. The finish call-out matters as much as the alloy — electropolish plus passivation is what survives repeated autoclaving.

### Can a supplier without ISO 13485 make parts for a medical device?

For many machined components, yes — the device maker holds the design controls and the machining supplier delivers to print with full documentation: material certificates to EN 10204 3.1, dimensional reports or CMM data, and FAI. We state plainly which certifications we do and do not hold, and quote the documentation scope at RFQ so your quality file is complete.

### What surface finish is needed on PEEK parts for medical use?

Machined PEEK typically holds Ra 0.4–0.8 µm as-cut with sharp tooling; where fluid paths or tissue contact demand better, we quote controlled finishing passes rather than polishing compounds that can embed. Material lot traceability travels with every batch because the resin grade is what your biocompatibility file rests on.