Medical Molding
From concept to prototypes to high volume manufacturing, Saint-Gobain is your trusted partner in producing custom molded medical device components.You will be paired with a dedicated applications engineer whom will provide feedback for design for manufacturability.We also provide a robust manufacturing plan including automation, full validation services, as well as regulatory expertise and advice to ensure you receive the quality medical device component you need.Our molding operations utilize ISO 7 and ISO 8 clean rooms (at rest) as well as use ISO 9001 and ISO 13485 certified quality systems.Contact us today to start your product realization journey.
Molding Capabilities:
- Manufacturing and packaging in ISO 7 and ISO 8 clean rooms at rest. Device establishments registered according to FDA 21 CFR 807Quality Managements Systems compliant with FDA 21 CFR 820
- In-house tool manufacturing and maintenance
- Full IQ/OQ/PQ validation services
- Fully automated manufacturing
- High-speed robotics
- Automated material handling systems
- Dedicated applications engineer for each project
- Dedicated manufacturing engineers each project
- Utilize World Class Manufacturing methodologies (i.e. Six Sigma, LEAN, Kaizen, 5S)
- Full range of value-added secondary services
- Conventional, insert, and two-shot medical molding
- Silicone, thermoplastic and thermoplastic elastomer molding