Our facility specializes in low to medium volume production of electromechanical medical devices. As a full service medical device manufacturer, we also pilot production for new product introduction for higher volumes. We have manufactured medical devices for sale in North America, Europe and Asia.
Our manufacturing process applies strict controls to deliver quality products on schedule. Our FDA registered manufacturing facility is certified to ISO 13485 and is compliant with the FDA Quality System Regulation (CFR 820) and includes a Class 100,000 Clean Room, with capabilities up to class 10,000, and certified Class 100 Laminar Flow Hoods. Regular audits and factory inspections by CSA ensure our quality system operates at the level of performance required to consistently produce high quality products.
Whether you choose pilot or long-term manufacturing (including medical device supply chain management), you maintain a single point of contact and accountability with a team that knows every detail of your product.
Standalone Manufacturing Services
As one of most experienced medical manufacturing companies in the world, even if we didn’t design your product we can still manufacture it.
Our expert knowledge of performance materials and production processes – along with our network of machining, tooling and fabrication partners – allow us to effectively handle any high-precision, short run medical device manufacturing you require. Should your needs change over time, we’ll also facilitate transfers to a higher volume contract manufacturing firm. Contact us to find out more.