Wise Plastics Technologies
Medical Device Injection Molding
ISO 13485:2016 certified thermoplastic and LSR molding for medical and pharmaceutical OEMs — 30 minutes from Chicago.
Medical Device Injection Molding — ISO 13485:2016 Certified
Medical OEMs need a molder whose quality system was built for audits, not adapted for them. Wise Plastics runs thermoplastic and liquid silicone rubber molding for medical and pharmaceutical programs under ISO 13485:2016, 30 minutes from Chicago.
Our quality management system is independently audited against the international medical device standard.
Medical Molding Capabilities
- Thermoplastic injection molding on 100+ presses, 35–1100 tons
- Liquid silicone rubber (LSR) molding on rotary, vertical, and horizontal machines (see LSR services)
- 2-shot and overmolding for soft-touch grips and multi-material devices
- Insert molding for metal-in-plastic components
- Scientific molding with documented, decoupled processes on every medical program
A Quality System Built for Medical
- ISO 13485:2016 and ISO 9001:2015 certified
- IQ/OQ/PQ process validation support
- Climate-controlled quality lab: Mitutoyo Crysta and Hexagon CMMs, vision systems, NIST-traceable calibration (see quality services)
- First article inspection and capability studies to your submission requirements
- Leak, flow, force, torque, and dimensional testing in-house
- Full lot traceability
Beyond Molding — Turnkey Medical Contract Manufacturing
One quality system from resin to shipped component: mechanical and electro-mechanical assembly, sonic welding and heat staking, pad printing and laser etching, functional testing, packaging and kitting.
Frequently Asked Questions
Discuss Your Device Program
Send prints or program requirements and we'll respond with a fit, risk, and timeline assessment from our medical team.
Discuss Your Device Program