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
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.
|Material||Temp. Resistance||Chemical Resistance||Good Clarity||Suitable for Skin Contact|
|PEEK, PEI (Ultem), PPSU||X||X|
|Liquid Silicone Rubber (LSR)||X||X||X|
Consultative Design Services
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