---
title: "ISO 13485 Shops: Get Medical Device Component RFQs | OpenSpindle"
description: "ISO 13485-certified or FDA-registered? OpenSpindle routes medical device component RFQs -- implants, surgical instruments, housings -- to shops that can run them. Free, no lead fees."
canonical: https://openspindle.com/for-shops/medical-devices
updated: 2026-08-31
---

# ISO 13485 medical shops: implant and instrument RFQs routed to you

**For: ISO 13485 / FDA-registered medical shops**

Medical device buyers need the quality system before they need the quote. If your shop holds ISO 13485 and runs biocompatible materials, we route the RFQs that match.

*Free to join* · *No lead fees* · *ISO 13485 only*

## Medical device RFQs on our board

### Orthopedic and dental implants

- Bone screws, plates, cages, and dental abutments in Ti-6Al-4V ELI (Grade 23)
- Cobalt-chrome (CoCrMo, ASTM F75) joint replacement geometry
- Full traceability from mill to packaging, electropolish partner required

### Surgical instruments and hand-pieces

- Reamers, drivers, retractors in 17-4 PH, 455 stainless, PEEK
- Swiss and 5-axis milled parts with surface finishes called out
- Passivation per ASTM A967 standard

### Housings, enclosures, and injection-molded parts

- Diagnostic equipment and point-of-care device housings in 6061 and medical polymers
- Insulin pump, infusion, and monitoring housings
- Prototype 1–50 with path to production

### Biocompatible polymer parts

- PEEK, UHMWPE, Delrin medical grade, and PPSU parts
- Validated sterilization paths (gamma, EtO) noted on RFQ

## What a qualified medical shop looks like

- **ISO 13485 (current):** Documented in your profile with scope and the registrar.
- **FDA facility registration:** If you handle finished devices or regulated components. Not required for all RFQs; call out your scope.
- **Material biocompatibility:** Implant-grade Ti-6Al-4V ELI, CoCrMo per ASTM F75, 316LVM, 455 and 17-4 PH stainless, medical polymers with full certs.
- **Finishing partners:** Electropolish, passivation, and glass-bead that meet medical cleanliness. In-house or named vendor.
- **Validated processes:** Where the device requires IQ/OQ/PQ, say so on your profile with the processes you have validated.
- **Lot traceability:** Material heat lot tied to serial-numbered parts; retention sample program.
- **Cleanroom (helps):** ISO Class 7 or 8 cleanroom assembly or packaging for implants and sterile devices.

## What a medical partner gets

- **Cert-matched RFQs only:** ISO 13485 RFQs go only to ISO 13485 shops. We do not send you non-regulated work to pad the stream.
- **Realistic schedules:** Medical FAI and sterilization lead time is set with the buyer up front; you quote the time you can hit.
- **Free to join; no fees:** No subscription, no per-RFQ fee, no commission on your price.
- **Material fronted:** Customer pays us before you cut; implant-grade stock on long lead is covered.
- **Keep your own customers:** Our RFQs are from new medical device buyers we bring in; we do not approach your existing accounts.

## Frequently Asked Questions

### We only quote regulated work. Will your RFQs waste our time?

If you set your profile to ISO 13485-only, we filter accordingly. You will not see unregulated commercial RFQs mixed in.

### How do you handle 21 CFR Part 11 and electronic records?

Documents and signatures tied to each RFQ are retained with the audit trail. If a buyer requires Part 11-compliant handling, we route only to shops set up for it.

### What volume should we expect?

Medical RFQ volume is steady with occasional production releases. Prototype quantities (1–50) are the majority, with low-volume production (100–5,000) as devices clear.

### Can we run both AS9100 and ISO 13485 work?

Many shops do; call out both scopes on your profile and we route matching RFQs from either side.

## Where the RFQs come from

- [Medical Devices](https://openspindle.com/industries/medical-devices.md) -- Primary industry page.
- [Titanium](https://openspindle.com/materials/titanium.md) -- Ti-6Al-4V ELI implant work.
- [Cobalt-Chrome](https://openspindle.com/materials/cobalt-chrome.md) -- CoCrMo implant and dental.
- [PEEK](https://openspindle.com/materials/peek.md) -- Spinal cages, instrument housings.
- [Swiss Machining](https://openspindle.com/capabilities/swiss-machining.md)
- [5-Axis Machining](https://openspindle.com/capabilities/5-axis-machining.md)
- [Micro Machining](https://openspindle.com/capabilities/micro-machining.md)

## Add ISO 13485 to your profile and we route the matching medical RFQs

Flag ISO 13485, FDA registration, and the biocompatible materials you handle. The next matching medical device RFQ comes to you.

[Apply as a shop partner](https://openspindle.com/apply.md)