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ISO 13485-aware partner shops. FDA-compliant documentation available.

Injection Molding for Medical Devices in Irving, TX

ISO 13485-aware partner shops. FDA-compliant documentation. 24-hour quotes for Class II device components serving the DFW medical corridor.

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±.002″
Best Tolerance

100+
Resins Available

24h
Quote Turnaround

2 wks
Rapid Tooling

// Overview

Irving sits at the center of the DFW industrial corridor, minutes from major medical device OEMs and the Las Colinas corporate campus where procurement teams move fast. If you’re sourcing injection-molded components for Class II medical devices, you need a partner who understands biocompatible material selection, FDA documentation requirements, and tight-tolerance repeatability — not just cycle times. Nimble connects Irving-area medical device manufacturers with a certified partner network that delivers production-grade plastic components with full traceability. Every quote includes free DFM feedback and CMM inspection data. We turn quotes in 24 hours — because your NPI schedule doesn’t wait.

// Capabilities

What we deliver in Irving, TX.

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Rapid Tooling (Aluminum)
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Production Tooling (P20 Steel)
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Overmolding & Insert Molding
✓
Multi-Cavity Tooling
✓
DFM & Mold Flow Analysis
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100% First Article Inspection

// Local Context

Irving, TX: Where DFW Med-Tech Procurement Gets Done

Irving’s Las Colinas district hosts a dense cluster of medical device and life sciences companies operating within the broader DFW metroplex — one of the fastest-growing medtech markets in the US. Proximity to UT Southwestern Medical Center, Baylor Scott & White supply chains, and major device distributors means Irving-based engineering teams are constantly sourcing precision plastic components under strict compliance requirements. Texas’s status as the #2 manufacturing state by output gives local buyers access to a deep, competitive supplier base — and Nimble’s certified partner network is built to match that pace.

Industries Served
Class II Medical Device OEMs and contract manufacturers in the DFW metroplexSurgical instrument and disposable device suppliers serving North Texas hospital systemsAerospace and defense electronics manufacturers in Irving requiring overmolded housings and EMI-shielded enclosuresIndustrial equipment manufacturers in the DFW corridor needing high-volume precision plastic components
Certification Note
ISO 13485-aware partner shops. FDA-compliant documentation available.

// Why Nimble

Precision without the procurement headache.

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ISO 13485-aware partner shops with FDA-compliant documentation packages available for Class II device submissions
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Biocompatible material expertise: USP Class VI, ISO 10993-tested resins including PEEK, PPSU, and medical-grade polycarbonate
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First Article Inspection (FAI) and CMM inspection reports included on every order — no upcharge, no negotiation
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Free DFM review on every quote flags sink marks, wall thickness issues, and gate placement before you cut steel
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24-hour quote turnaround built for Irving procurement teams running parallel NPI programs across multiple device lines

// FAQ

Common questions about Injection Molding for Medical Devices in Irving, TX.

Can you produce injection-molded components that meet FDA 21 CFR Part 820 documentation requirements for our Irving-based device program?
Yes. Our certified partner network includes ISO 13485-aware shops that can generate FDA-compliant documentation packages — including material certifications, process validation support, and inspection records — aligned with 21 CFR Part 820 quality system requirements. We coordinate documentation deliverables at the quoting stage so there are no surprises at submission.

What biocompatible resins can you mold for Class II device components?
Our partner network routinely processes USP Class VI and ISO 10993-tested materials including medical-grade polycarbonate, PEEK, PPSU, ULTEM, ABS, and TPE overmolding compounds. Material traceability documentation and certificates of conformance are available for all production runs.

We’re an Irving-based startup preparing for FDA 510(k) submission — can Nimble support low-volume pilot builds before full production?
Absolutely. We support bridge tooling and pilot production runs as low as a few hundred parts, with the same FAI, CMM inspection, and documentation rigor as full production. This is a common path for DFW medtech startups validating device designs ahead of regulatory submission.

How close are your partner shops to Irving, TX, and does proximity affect lead times?
Nimble operates a distributed certified partner network across the US, not a single facility. We route your program to the partner shop best matched to your material, tolerance, and compliance requirements — not just geography. That said, Texas has a strong manufacturing base and regional partners are frequently engaged for DFW-area programs. Quotes arrive in 24 hours regardless of shop location.

Our device enclosure requires both injection-molded structural parts and secondary surface finishing — can Nimble handle both?
Yes. Beyond injection molding, our certified partner network covers surface finishing including painting, pad printing, ultrasonic welding prep, and texture matching for device-grade aesthetics. We manage the full scope under a single quote and single point of contact — no vendor-juggling for your Irving procurement team.

// Request a Quote

Tell us about
your project.

Upload your drawings or CAD files and we’ll respond with a detailed quote within 24 hours. No NDA required to get started.

STEP, IGES, DXF, DWG, PDF accepted

Quotes back within 24 hours

Free DFM feedback on every quote

All files kept strictly confidential

Prefer email? Reach us at
quote@nimblemfg.co




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STEP · IGES · DXF · DWG · PDF

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Ready to source Injection Molding in Irving, TX?

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