MedMoldPro — About Us
Precision Injection Molding for Medical Devices
Who We Are
Purpose-Built for Medical Manufacturing-
MedMoldPro is the medical device injection molding division of CKMOLD, established to serve an industry where tolerances are measured in microns, and errors are not an option. While CKMOLD has spent 20 years mastering precision plastic injection molding across industries, MedMoldPro exists for one reason: to give medical device companies a partner that understands regulatory demands, biocompatibility requirements, and cleanroom manufacturing as a daily standard, not a special request.
We work with diagnostic equipment manufacturers, surgical instrument brands, drug delivery system developers, and IVD companies to bring components from concept to validated, mass-produced reality.
Why a Dedicated Medical Division
Why MedMoldPro Exists-
Medical injection molding is not general injection molding with extra paperwork. It requires:
Cleanroom-controlled production (ISO Class 7/8) to prevent contamination
Full material traceability from resin lot to finished part
Validated processes (IQ/OQ/PQ) that satisfy FDA and international auditors
Biocompatible, medical-grade resins (USP Class VI, ISO 10993 compliant)
Documentation discipline that stands up to regulatory scrutiny
MedMoldPro was built around these requirements from day one — not adapted from a general-purpose production line.
Backed by CKMOLD
The Strength of CKMOLD, Focused on Medical-
MedMoldPro operates as part of the CKMOLD group, drawing on 20+ years of tooling and molding expertise, 15+ precision molding machines, and a proven track record across automotive, consumer electronics, and industrial sectors.
That foundation means our medical customers benefit from:
Deep in-house mold design and tooling engineering
Manufacturing scale and redundancy for reliable supply
Cross-industry process knowledge applied to medical-grade precision
MedMoldPro is where CKMOLD’s manufacturing strength meets the specific demands of medical device production.
Our Capabilities
What We Manufacture-
- Diagnostic device housings & components
- Surgical instrument handles and components
- Drug delivery system parts (inhalers, auto-injectors, pump housings)
- IVD (In Vitro Diagnostic) consumables & cartridges
- Catheter components & connectors
- Micro-molded precision parts
Quality & Compliance
Quality Isn’t a Department. It’s the Process-
Every project at MedMoldPro runs through a validated quality system designed around medical device requirements:
ISO 13485-certified quality management system
ISO 7/8 Cleanroom manufacturing environments
Full material & process traceability for every batch
DHR (Device History Record) documentation on request
Our Process
From Concept to Validated Production-
- DFM Review — Design for Manufacturability analysis with your engineering team
- Mold Design & Tooling — Precision tool build with medical-grade steel
- Process Validation — IQ/OQ/PQ validation runs
- Cleanroom Production — Controlled, repeatable, documented manufacturing
- Quality Inspection & Traceability — Full documentation per shipment
Let's Build Your Next Medical Component
Whether you’re moving from prototype to production, or need a second-source manufacturer who won’t compromise on compliance, MedMoldPro is ready to be your medical injection molding partner.