1. FDA registration and a medical quality system
A supplier to medical device OEMs should be registered with the FDA and run a quality management system built around ISO 13485 and current good manufacturing practice (cGMP). Ask how long they've been registered and whether they've hosted OEM supplier audits.
2. Documentation you can file
Every order should come with the records your quality team needs, without chasing them.
- First article inspection (FAI) report
- Certificate of conformance
- Material certifications
- Lot traceability
- PPAP or IQ/OQ/PQ support when your program requires it
3. Medical materials experience
Titanium, 316L stainless, PEEK, and Nitinol each behave differently under a cutter. Ask to see parts in the materials you'll use.
4. Prototype through production
Switching from a prototype shop to a production shop usually means re-qualifying a supplier. A shop that does both carries the same programs, fixtures, and inspection plan forward, which saves months.
5. Location and access
A Florida-based supplier means same-state shipping, no customs, and the ability to walk the floor. In South Florida, a Palm Beach County shop is within about 90 minutes of Miami, Fort Lauderdale, Boca Raton, and the Treasure Coast.
6. The right product fit
Match the shop to the job. Some shops are built for millions of disposable parts; others for durable, reusable equipment, repeat production, and repair. Ask what their best-fit work looks like.
7. Who answers the phone
When a part is on hold, you want an engineer who knows it, not a ticket queue. Ask who you'll actually be working with.