# Medical devices and lab equipment metal fabrication: standards and how to choose | Best Fabricators

Source: https://bestfabricators.com/industries/medical/

# Medical devices and lab equipment fabrication

Medical fabrication produces device components, instrument parts, carts, and lab and cleanroom equipment.

## Materials and processes

316L stainless steel, titanium, and aluminum, often laser cut and laser or TIG welded, then electropolished or passivated.

## Standards and certifications to know

- ISO 13485: the quality management standard for medical device manufacturing.
- FDA Quality Management System Regulation (21 CFR Part 820): the U.S. device quality rule, aligned with ISO 13485 as of February 2026.
- ASTM F138 and F136: common specifications for implant-grade stainless steel and titanium.

## Questions to ask a shop

- Is the shop ISO 13485 certified, or does it work under your quality system?
- Can it provide full lot traceability and material certifications?
- Does it have cleanroom or controlled-environment assembly if you need it?
- Can it electropolish or passivate and document the result?

## What drives cost

Validation, documentation, inspection, specialty alloys, and small lot sizes drive price.

## Metros with strong local demand

- [Medical device fabrication in Baltimore, MD](https://bestfabricators.com/metal-fabrication/baltimore-md/)
- [Medical device fabrication in Cleveland, OH](https://bestfabricators.com/metal-fabrication/cleveland-oh/)
- [Medical device fabrication in Houston, TX](https://bestfabricators.com/metal-fabrication/houston-tx/)
- [Medical device fabrication in Indianapolis, IN](https://bestfabricators.com/metal-fabrication/indianapolis-in/)
- [Medical device fabrication in Los Angeles, CA](https://bestfabricators.com/metal-fabrication/los-angeles-ca/)
- [Medical device fabrication in Minneapolis, MN](https://bestfabricators.com/metal-fabrication/minneapolis-mn/)
- [Medical device fabrication in Boston, MA](https://bestfabricators.com/metal-fabrication/boston-ma/)
- [Medical device fabrication in New York, NY](https://bestfabricators.com/metal-fabrication/new-york-ny/)
- [Medical device fabrication in Philadelphia, PA](https://bestfabricators.com/metal-fabrication/philadelphia-pa/)
- [Medical device fabrication in Pittsburgh, PA](https://bestfabricators.com/metal-fabrication/pittsburgh-pa/)
- [Medical device fabrication in San Francisco Bay Area, CA](https://bestfabricators.com/metal-fabrication/san-francisco-ca/)
- [Medical device fabrication in Nashville, TN](https://bestfabricators.com/metal-fabrication/nashville-tn/)

## Questions

### What should I look for in a medical device fabricator?

Relevant certifications, finished work similar to yours, the right equipment, and clear documentation. Start with: Is the shop ISO 13485 certified, or does it work under your quality system?

### Where is medical device fabrication concentrated?

On this site, these metros have strong local demand: Baltimore, MD, Cleveland, OH, Houston, TX, Indianapolis, IN, Los Angeles, CA, Minneapolis, MN, Boston, MA, New York, NY, Philadelphia, PA, Pittsburgh, PA, San Francisco Bay Area, CA, Nashville, TN.

Related: [Fabrication certifications explained](https://bestfabricators.com/guides/certifications/) · [Fabrication processes](https://bestfabricators.com/guides/metal-fabrication-processes/)

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