Medical device component manufacturing, traceable to the shop that made it.

Stainless steel surgical scalpel with a textured handle

A beautiful drawing is only useful when the device works—and the paperwork follows.

From prototypes to production, we coordinate precision components, materials, manufacturing processes, and appropriate inspection documentation. Your team works with a dedicated project manager instead of managing multiple shops.

CERTIFICATIONS + COMPLIANCE
ISO 13485 Compliant · AS9100D Compliant · ISO 9001:2015 · ITAR Registered · NIST 800-171 Compliant

Medical Device manufacturing capabilities

  • CNC Machining

    Milling + Swiss turning for instrument parts, housings and precision features through vetted shops.

  • Sheet Metal Fabrication

    Enclosures, chassis + brackets for diagnostic and capital equipment.

  • Injection Molding

    Device housings, handles + related components in specified resin grades.

  • Industrial 3D printing

    Fit checks, housings + complex geometry with suitability reviewed for the application.

  • Finishing + Post-Processing

    Passivation, electropolish, anodize, bead blast + laser marking to specified requirements.

  • Engineering Support + DFM

    Drawing review, tolerance feasibility + DFM feedback before design transfer.

Why medical device teams call us

01

A Record for Every Part

Material certs, inspection records + agreed traceability documentation coordinated with the order.

 

02

Vendors Qualified for Regulated Work

The program matched to the manufacturing qualifications, material experience + process controls it requires.

 

03

Engineer Review Before Sourcing

Material callouts, critical dimensions, finish + documentation requirements reviewed before release.

Where medical device teams bring us in

The handoffs where paper trails usually break.

Design transfer is approaching

We coordinate the move to a qualified production source while keeping the context with the same contact.

The next lot has to match

Finish, color + cosmetic acceptance criteria established at quote and checked against agreed requirements.

Machined, molded, and assembled on one date

The processes run as one coordinated program, with documentation planned alongside the parts.

One contact. Zero chasing.

One project manager knows the design-transfer timeline, required records + manufacturing route. Your team gets answers without reconstructing supplier history.

A track record behind the promise

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CUSTOMERS SERVED

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PARTS DELIVERED

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ON-TIME DELIVERY

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CAPABILITIES

A few things worth asking

Precision Expedited is ISO 13485 compliant. Our vendor network includes ISO 13485 certified manufacturing partners, so programs that require a certified source go to one. Every medical device order includes 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.

Our vetted network routinely holds 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.

Quick-turn portals match your job to whoever’s available, without a drawing review, a dedicated contact, or a guarantee that the vendor understands ISO 13485. They’re fast on simple parts, but they’re not built for the documentation requirements of regulated medical programs. We’re 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.

You’ve got the next big thing. We’ll handle how it gets made.

A real person responds to your RFQ within 24 hours.