--- title: "Medical Device Manufacturing | ISO 13485 & FDA Shops | OpenSpindle" description: "Find independent machine shops for medical device parts. ISO 13485 and FDA-registered shops for implants, instruments, and biocompatible components. Upload a drawing." canonical: https://openspindle.com/industries/medical-devices --- # Medical device manufacturing partners Medical device parts demand tight tolerances, biocompatible materials, and a quality system you can trust. Find independent machine shops set up for medical work, then talk directly to the shop making your part. **Certifications:** ISO 13485, FDA Registered, ISO 9001, Cleanroom ## Medical device shops on OpenSpindle Real shops that machine and fabricate medical device parts. See their equipment and certifications, and talk to the person making your part. [Browse all medical device shops](https://openspindle.com/manufacturers?q=Medical) ## Certifications 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. ## Capabilities for This Industry - [Swiss Machining](https://openspindle.com/capabilities/swiss-machining.md) -- Small, high-precision implants and instruments turned from bar stock in one operation. - [CNC Machining](https://openspindle.com/capabilities/cnc-machining.md) -- Milled housings, brackets, and instrument bodies in stainless, titanium, and PEEK. - [CNC Turning](https://openspindle.com/capabilities/cnc-turning.md) -- Turned shafts, pins, screws, and fittings to tight tolerances. - [5-Axis Machining](https://openspindle.com/capabilities/5-axis-machining.md) -- Complex contoured implants and instrument geometry in a single setup. - [EDM & Wire EDM](https://openspindle.com/capabilities/edm.md) -- Fine detail, sharp internal corners, and hardened alloys milling cannot reach. - [Laser Cutting](https://openspindle.com/capabilities/laser-cutting.md) -- Precision cutting of thin-gauge stainless and titanium for instrument components. ## Common Materials - [Stainless Steel](https://openspindle.com/materials/stainless-steel.md) -- 316L and 17-4 PH for corrosion-resistant instruments and device bodies. - [Titanium](https://openspindle.com/materials/titanium.md) -- Grade 5 and Grade 23 (Ti-6Al-4V ELI) implant-grade alloys. - [PEEK](https://openspindle.com/materials/peek.md) -- Biocompatible high-performance polymer, including implantable grades. - [Aluminum](https://openspindle.com/materials/aluminum.md) -- 6061 and 7075 for instruments, enclosures, and non-implant hardware. - [Delrin](https://openspindle.com/materials/delrin.md) -- Acetal for wear surfaces, housings, and non-implant components. ## Typical Parts - Surgical instruments - Implants - Instrument housings - Bone screws & fasteners - Handpieces & shafts - Fixtures & trays - Sensor housings ## Why OpenSpindle - **Talk directly to the shop:** No account manager in the middle. You work with the shop actually making your part, which matters when a device drawing needs a real engineering conversation. - **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. ## Frequently Asked Questions ### Do the shops hold ISO 13485? 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. ### Can shops work with biocompatible and implant-grade materials? Yes. Shops routinely machine 316L and 17-4 PH stainless, Grade 5 and Grade 23 ELI titanium, and implantable PEEK. Specify the exact grade and any material certifications or biocompatibility documentation (ISO 10993) you need, and shops will source certified stock with traceability. ### Do shops offer cleanroom processing and passivation? Some medical shops provide cleanroom assembly or packaging and standard finishing such as passivation, electropolishing, and cleaning. Ask about cleanroom class and validated processes when your part requires them, and confirm the shop can meet your specification. ### Can I get low-volume or prototype medical parts? Yes. Independent shops regularly quote single prototypes, verification builds, and low-rate production. Expect a setup charge on one-offs that drops on repeat orders. Note your quantity and any inspection requirements in the request. ### Do shops provide traceability and device history records? Medical shops typically provide material certifications, certificates of conformance, and lot traceability, and many maintain the documentation that supports a device history record (DHR). Specify the documentation and inspection reports you need so shops quote them in. ### What tolerances can medical shops hold? Precision medical shops commonly hold milled features to around plus or minus 0.001 to 0.002 inch, with Swiss turning and grinding for the critical diameters and surface finishes. Call out the datums, critical dimensions, surface finish, and inspection level on your drawing. ### What files should I send for a quote? STEP, IGES, X_T, or a fully dimensioned PDF drawing with datums, GD&T, material and grade, surface finish, quantity, and inspection requirements. Note any biocompatibility, cleanroom, or documentation needs so shops quote them accurately. ## Related Industries - [Aerospace & Defense](https://openspindle.com/industries/aerospace-defense.md) - [Robotics & Automation](https://openspindle.com/industries/robotics-automation.md) - [Energy / Oil & Gas](https://openspindle.com/industries/energy-oil-gas.md) - [Electronics](https://openspindle.com/industries/electronics.md) - [Automotive](https://openspindle.com/industries/automotive.md) - [Architecture & Construction](https://openspindle.com/industries/architecture-engineering-construction.md) ## Get medical device quotes Upload a drawing once and compare quotes from independent shops with the quality system your part needs.