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.
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- Minimum order
- 1 part
- Typical lead time
- 1 to 4 weeks
- Core materials
- Titanium, PEEK, 316L
- Standard
- ISO 13485
Processes
Capabilities for medical devices
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.
Materials
Materials for medical devices
Reference
Material selection for medical device parts
| Component | Typical material | Why it fits |
|---|---|---|
| Implants & surgical | Titanium Ti-6Al-4V ELI | Biocompatible, strong, corrosion-resistant |
| Instruments & fixtures | 316L stainless steel | Sterilizable, corrosion-resistant, biocompatible |
| Spinal & load-bearing | PEEK | Biocompatible, radiolucent, bone-like modulus |
| Housings & enclosures | Aluminum 6061, ABS | Light, machinable non-implant housings |
| Low-friction mechanisms | Delrin (acetal) | Clean-machining and wear-resistant |
| Articulating surfaces | Cobalt-chrome | Hard, biocompatible bearing surfaces |
Applications
Typical medical devices parts
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.
More industries
Other industries we serve
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.
STEP · STL · IGES · DWG · DXF · PDF · and more
Uploads are secure & confidential