Medical-Grade Injection Molding, Engineered for Zero Compromise
Cleanroom manufacturing, full traceability, and validated processes for the medical devices that can’t afford to fail.
A Medical Injection Molding Partner That Speaks Your Language
MedMoldPro is the dedicated medical device division of CKMOLD. We manufacture precision plastic components for diagnostic equipment, surgical instruments, drug delivery systems, and IVD products — under a quality system built specifically for regulated medical production, not adapted from general industry standards.
From DFM review through validated mass production, we work as an extension of your engineering and regulatory team.
What We Manufacture
- Diagnostic Device Components: Housings, cartridges, and structural parts for diagnostic instruments
- Surgical Instrument Parts: Handles, connectors, and precision components for surgical tools
- Drug Delivery Systems: Auto-injector housings, inhaler components, pump parts
- IVD Consumables: High-volume, tight-tolerance cartridges and test components
- Catheter & Connector Components Micro-precision parts for minimally invasive devices
- Custom Micro-Molding: Ultra-precise parts for complex, small-scale applications
Why MedMoldPro-Built for the Standards Medical Manufacturing Demands
- Cleanroom Manufacturing ISO Class 7/8 environments controlling contamination at every stage
- Full Traceability Every resin lot, every batch, documented from material to finished part
- Validated Processes IQ/OQ/PQ validation protocols that satisfy regulatory audits
- Backed by CKMOLD’s Scale 20+ years of precision tooling expertise and 15+ molding machines behind every project
Our Process-From Concept to Validated Production
- DFM Review — Manufacturability analysis with your engineering team
- Mold Design & Tooling — Precision medical-grade tool build
- Process Validation — IQ/OQ/PQ validation runs
- Cleanroom Production — Controlled, repeatable, documented manufacturing
- QC & Traceability — Full documentation with every shipment
Industries We Serve-Trusted Across the Medical Device Landscape
- Diagnostic & Laboratory Equipment
- Surgical & Minimally Invasive Devices
- Drug Delivery & Wearable Devices
- In Vitro Diagnostics (IVD)
- Cardiovascular & Catheter-Based Devices
MedMoldPro — FAQ Section
MedMoldPro operates under an ISO 13485-certified quality management system, with manufacturing conducted in ISO Class 7/8 cleanroom environments. Full documentation, including certificates and audit reports, is available upon request during the qualification process.
Yes. We provide the documentation regulatory teams typically need — including material certifications, process validation records (IQ/OQ/PQ), and Device History Records (DHR) — to support your 510(k), PMA, or CE marking submissions. We work directly with your regulatory affairs team to ensure documentation matches your specific submission requirements.
We mold with USP Class VI and ISO 10993-compliant resins, including medical-grade polycarbonate, PEEK, POM, and various biocompatible thermoplastics. If your project specifies a particular resin grade or supplier, we source and validate accordingly — material substitution without your sign-off never happens.
Yes. Many of our medical device partners start with prototype or low-volume validation runs before scaling to full production. We support both stages under the same quality system, so parts validated early in the process carry through to mass production without re-qualification surprises.
Every resin lot, mold cycle, and finished part batch is logged and linked, so any component can be traced back to its raw material source. This traceability record is available with every shipment and can be formatted to match your internal quality documentation requirements.
MedMoldPro is CKMOLD’s dedicated medical device division. While CKMOLD serves industries like automotive and consumer electronics, MedMoldPro operates under a separate, medical-specific quality framework — cleanroom production, ISO 13485 compliance, and validation protocols that general manufacturing lines aren’t built around. You get CKMOLD’s manufacturing scale, with processes designed specifically for regulated medical production.
Ready to Move Your Medical Device from Prototype to Production?
Tell us about your project — our engineering team will review feasibility and respond within 1 business days.