Medical Device Injection Molding
ISO 13485-certified injection molding service for plastic medical
device components
Our medical molding service allows you to leverage the speed-in-development you are used to in the high-requirement environment of the medical space. Our team of medical molding manufacturing experts helps you take FDA Class I and II devices, or non-implantable components, quickly from prototype to production and is viable through regulatory body submissions.
Molding Capabilities for Medical Devices
Certification: ISO 13485 (Strategic partnership)
Clean Rooms: Class 8 rooms available
Steel tooling: P20 and hardened steel available
Process Validation: Achievable by standardized qualification package, industry-accepted protocol, or customer-defined
| MATERIAL | Temp. Resistance | Chemical Resistance | Good Clarity | Suitable for Skin Contact |
| PEEK, PEI (Ultem), PPSU |
Yes |
Yes |
|
|
| Polycarbonate (PC) |
|
|
Yes |
|
| PLiquid Silicone Rubber (LSR) |
Yes |
Yes |
|
Yes |
Available Medical-Grade Plastic/Resins
We carry the most common types of plastics and resins used in medical molding. We can also accommodate customer-supplied resins and provide custom color matching.
Customer Supplied Resin: Need to use a material that we don't stock? No problem. Simply fill out this form to supply your own resin.
Custom Colorant: We can also develop custom colorant to match a Pantone color or physical sample. The process is simple and fast. After we receive your color request, we’ll send you a sample plaque for approval in as fast as three days. Learn more here.
How We Can Help
With no minimum order quantities and a free prototype tool with on-demand manufacturing orders, we’re your partner to get to market faster for projects like:
Lower volume or difficult-to-forecast products
FDA Class I and II devices, or non-implantable components
Early-in-development projects
Components requiring complicated supply chains
Development stages that require design flexibility
Parts in which we can apply early process learnings to production
SKUs that could benefit from a secondary source
Design verification testing, clinical trial submissions, and regulatory body submission
