HomeInjection MoldingRochester, MNMedical Devices
ISO 13485-aware partner shops. FDA-compliant documentation available.

Injection Molding for Rochester’s Medical Device Engineers

Mayo Clinic’s backyard demands precision. Our certified partner network delivers biocompatible injection molded components with FDA-compliant documentation and 24-hour quotes.

Request a Quote →
View All Capabilities

±.002″
Best Tolerance

100+
Resins Available

24h
Quote Turnaround

2 wks
Rapid Tooling

// Overview

Rochester, MN isn’t a typical manufacturing hub — it’s a medical device proving ground. With Mayo Clinic driving constant demand for surgical instrument components, diagnostic housings, and Class II device parts, the bar for injection molded plastics is exceptionally high. Our certified partner network sources ISO 13485-aware shops capable of molding biocompatible resins — PEEK, Ultem, medical-grade polycarbonate — with full traceability documentation. Whether you’re a Mayo spin-out prototyping a surgical tool or a Tier 1 supplier delivering production runs for Medtronic’s Rochester-area operations, we quote in 24 hours with DFM included.

// Capabilities

What we deliver in Rochester, MN.


Rapid Tooling (Aluminum)

Production Tooling (P20 Steel)

Overmolding & Insert Molding

Multi-Cavity Tooling

DFM & Mold Flow Analysis

100% First Article Inspection

// Local Context

Built for Rochester’s Medical Manufacturing Ecosystem

Rochester sits at the center of Minnesota’s $10B+ medical device corridor. Mayo Clinic’s device innovation pipeline, combined with proximity to Medtronic’s Minneapolis headquarters and Abbott’s St. Jude legacy facilities, means local engineers routinely need injection molded components that meet FDA scrutiny from day one. IBM’s Rochester presence adds demand for precision enclosures and technical polymer components across adjacent programs.

Industries Served
Medical Devices & Surgical InstrumentsDiagnostic Equipment & Imaging ComponentsIndustrial & Lab Automation EquipmentAerospace & Defense Subcomponents
Certification Note
ISO 13485-aware partner shops. FDA-compliant documentation available.

// Why Nimble

Precision without the procurement headache.


ISO 13485-aware partner shops — documentation structured for FDA submissions and Class II device audits

Biocompatible resin expertise: PEEK, Ultem, USP Class VI polycarbonate, medical-grade ABS — material certs included

CMM inspection and First Article Inspection on every production order — no chasing paperwork

24-hour quote turnaround with free DFM review — critical when Mayo Clinic timelines don’t wait

ITAR-registered network for Rochester defense and aerospace crossover programs alongside medical work

// FAQ

Common questions about Injection Molding for Medical Devices in Rochester, MN.

Can you mold components that meet FDA requirements for Class II medical devices in Rochester?
Yes. Our certified partner network includes ISO 13485-aware shops that provide full material traceability, process documentation, and First Article Inspection reports structured for FDA 510(k) submissions. We work with USP Class VI and ISO 10993-compliant materials on request.

What biocompatible materials are available for injection molding?
We regularly mold medical-grade polycarbonate, PEEK, Ultem 1010, USP Class VI polypropylene, medical ABS, and PPSU. Material certifications and resin lot traceability are included — essential for Mayo Clinic supplier qualification and Medtronic-tier supply chains.

How fast can you quote an injection mold for a surgical instrument component?
24 hours. Upload your CAD file and we return a quote with DFM feedback, tooling cost, cycle time estimate, and per-part pricing. If your geometry has issues, we flag them before you spend a dollar on tooling.

Do your partner shops offer clean room molding or clean room packaging for medical parts?
Clean room assembly and packaging options are available through select partners in our network. Confirm your cleanliness requirements — ISO Class 7 or 8 — at quoting and we match you to the right shop. This matters for implantable-adjacent and sterile-packaged device components.

We’re a Rochester-based startup spun out of Mayo Clinic — can you handle low-volume prototype tooling?
Absolutely. Prototype aluminum tooling for 50–500 parts is a common starting point for Mayo spin-outs validating device designs. We scope tooling cost against your volume needs and transition you to hardened steel production tooling when you’re ready to scale — no need to re-source a new partner.

// 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




Drop files or click to browse
STEP · IGES · DXF · DWG · PDF

We respond within 24 hours · All files kept confidential

Ready to source Injection Molding in Rochester, MN?

Upload your drawings and get a detailed quote within 24 hours. Free DFM review included.

Request a Quote →