Single-use, disposable products in sterilized packaging are a booming segment. But manufacturing, assembling and packaging these medical devices requires the use of certified Clean Rooms and other advanced technology to avoid contamination and meet stringent compliance requirements.
It’s a challenge for OEMs and startups, especially when scaling production volumes. Clean Rooms are capital-intensive to build, time-consuming to maintain, and require ISO13485:2016 certification, making in-house manufacturing both financially risky and resource-intensive.
Sterling Industries has over X,000 square feet of flexible and compliant Class 7 Clean Room space. We have deep experience in designing and maintaining workflows for manufacturing, assembling and packaging that ensure cost-efficiency, repeatability, quality and compliance.
Besides familiar single-use categories like syringes, catheters and surgical instruments, we are seeing rapid growth in innovative single-use medical devices that include sophisticated digital functionality.
Falling costs for single-board computers (SBCs), microcontrollers, optics and sensors, combined with rising costs and stricter compliance procedures for sterilization of traditional, re-usable devices is leading to an impressive new category of complex, single-use devices that can replace capital-intensive multi-use systems that are expensive to maintain and re-sterilize. We have experience with single-use, digital imaging solutions, including arthroscopes and endoscopes, as well as wireless sensors and diagnostic testing kits that include advanced microelectronics.
If you design and market single-use, sterilized medical devices, you are already know the production and compliance challenges your product faces. Sterling offers solutions, based on real-world experience.
Get in touch to learn how we can help scale your production.
At Sterling Industries, we manufacture success.
6825 Beatrice Drive
Kalamazoo, MI
49009
10 Whitmore Road
Woodbridge, ON
L4L 7Z4
295 Connie Crescent
Concord, ON
L4K 5R2
72 Churchill Drive
Barrie, ON
L4N 8Z5