ISO 13485 medical device components. Every part traced, every vendor vetted
Full traceability on every medical device component we source. Our engineers review your drawings before manufacturing starts because, in medical, a problem caught early beats one caught late.
Every vendor in our network is vetted for documentation and process control before your work goes in front of them. CNC machining + injection molding + additive, coordinated through a single point of contact who knows your program. Send us the drawings.
Proof is in the parts.
CUSTOMERS SERVED
PARTS DELIVERED
ON-TIME DELIVERY
CAPABILITIES
Three steps from RFQ to delivery
Simple front end. Controlled execution behind it.
Send Your RFQ
Every quote starts with a drawing review. Real number back within 24 hours. DFM flags and regulatory risk called out before anything goes to a supplier.
We Manage the Details
We coordinate sourcing across ISO 13485-certified suppliers, manage documentation requirements, and keep traceability in scope from the first quote. You don’t manage the compliance overhead. We do.
We Inspect and Deliver
Every part inspected at our San Clemente facility before it ships. Documented to drawing. Delivered on spec. Because in medical device, a quality escape isn’t a delay. It’s a program risk.
“Everything was dead on spec. Keep sending us beautiful, perfect parts early, and we’ll keep sending you our business.”
— Adam N., Senior Mechanical Engineer
Medical Industry FAQs
Yes. Precision Expedited is ISO 13485 certified and ISO 9001:2015 certified. Our vendor network includes ISO 13485–registered manufacturing partners vetted for regulated-industry experience. Every medical device order includes full quality documentation — material certifications, inspection records, and traceability documentation — without you having to ask for it separately.
Full traceability is available on every order. Material certifications, first article inspection reports, supplier documentation, and inspection records are maintained throughout the project. If your quality system or regulatory submission requires a complete paper trail, we have it ready. Note this requirement with your RFQ and we’ll confirm the documentation package before quoting.
We routinely hold tolerances to ±0.001″ across 3, 4, and 5-axis CNC machining. For tighter GD&T requirements or micro-precision features, share your 2D print and we’ll review it during the quoting process. Our engineer review step flags tolerance feasibility and material compatibility before production starts — not after.
Yes. We support one-offs through full production runs with the same engineer review and quality inspection at every stage. Many of our medical device customers start with a prototype, move through design transfer, and scale to bridge production and volume manufacturing — all through the same single contact.
Titanium (Grade 2, Grade 5 / Ti-6Al-4V), medical-grade stainless steel (316L, 17-4 PH), aluminum (6061, 7075), PEEK, Delrin, UHMWPE, and other biocompatible and high-performance polymers. Specify your material callout and any biocompatibility requirements on your print and we’ll confirm availability and compliance during quoting.
Platforms like Xometry match your job to whoever is available — no drawing review, no dedicated contact, no guarantee the vendor understands ISO 13485. Protolabs is fast on simple parts but is not built for the documentation requirements of regulated medical programs. We are built for exactly this: complex parts, vetted vendors, engineer review before anything goes to the floor, and a single contact who owns your traceability documentation from RFQ through delivery. That’s the difference.