Industry

Get quotes for custom medical device parts

Surgical instrument components, implant geometry, housings, and fixtures in biocompatible metals and polymers. Upload your CAD files or drawings and we'll source competitive quotes from qualified manufacturing partners running ISO 13485 quality systems.

ISO 13485FDA RegisteredISO 9001Cleanroom
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Minimum order
1 part
Typical lead time
1 to 4 weeks
Core materials
Titanium, PEEK, 316L
Standard
ISO 13485

How OpenSpindle works

We tap our partner network. You get the best-match quote.

Upload your part and we tap our network of partner shops to get you a competitive, all-in quote that is the best match for the job.

One upload

A CAD file or a sketch. That is the whole ask on your end.

Your best-match quote

Sourced from the partner shops set up for your exact part.

All-in, on your timeline

Machining, finishing, and shipping detailed to your turnaround.

Reference

Material selection for medical device parts

Common medical components and biocompatible materials. Confirm grade, biocompatibility, and any ISO 13485 requirements with the shop.
ComponentTypical materialWhy it fits
Implants & surgicalTitanium Ti-6Al-4V ELIBiocompatible, strong, corrosion-resistant
Instruments & fixtures316L stainless steelSterilizable, corrosion-resistant, biocompatible
Spinal & load-bearingPEEKBiocompatible, radiolucent, bone-like modulus
Housings & enclosuresAluminum 6061, ABSLight, machinable non-implant housings
Low-friction mechanismsDelrin (acetal)Clean-machining and wear-resistant
Articulating surfacesCobalt-chromeHard, biocompatible bearing surfaces

Applications

Typical medical devices parts

Surgical instruments
Implants
Instrument housings
Bone screws & fasteners
Handpieces & shafts
Fixtures & trays
Sensor housings

Why OpenSpindle

Built for medical devices buyers

Real quotes, not estimates

Your part is quoted by independent shops set up for medical work, so the price reflects the real job, not an automated estimate that changes later.

No sales gate

Upload a drawing and request quotes without a sales rep or account manager in the middle. Faster than the login-walled portals.

Compare multiple shops

See several independent shops with the quality system your part needs, and compare quotes rather than taking a single price.

Certifications up front

Shops list their ISO 13485, FDA registration, and ISO 9001 status on their profile, so you can shortlist before you send a drawing.

Trust

Certifications and standards that matter

For medical device work, the quality system is the gate. Look for these on a shop before you send a drawing, and confirm the specific scope for your part.

ISO 13485

The quality management standard written specifically for medical devices. It is the baseline expectation for shops making device components, covering process control, traceability, and risk management.

FDA Registered

Facility registration with the U.S. Food and Drug Administration for establishments that manufacture medical devices. Required when a shop is part of the regulated device supply chain.

ISO 9001

The general quality management baseline. Common on shops that also carry ISO 13485, and sufficient for non-device components, instruments tooling, and prototypes.

Cleanroom & Process Validation

Controlled-environment assembly or packaging (for example ISO Class 7 or 8) plus validated, documented processes. Ask about cleanroom class and validation when your part requires it.

Material Biocompatibility (ISO 10993)

The evaluation framework for biological safety of materials that contact the body. Shops should provide certified biocompatible or implant-grade stock with full material traceability.

Questions

Frequently asked questions

Many medical shops on OpenSpindle carry ISO 13485, and they list it on their profile alongside FDA registration and ISO 9001. For device components, shortlist ISO 13485 shops and confirm the certification is current and covers your process.

Sourcing guides

Deciding where to make your parts

Last reviewed August 2026

Get medical device quotes

Upload your drawing and we'll source competitive quotes from qualified manufacturing partners with the quality system your part needs.

Upload Files & Get Free Quotes

STEP · STL · IGES · DWG · DXF · PDF · and more

Uploads are secure & confidential

No CAD file?