Manufacturing
Low volume, high complexity manufacturing
Our facility specializes in low to medium volume production of electromechanical medical devices. In addition, we can do pilot production for new product introduction for higher volumes. We have manufactured medical devices for sale in Canada, the USA, the EU and the Far East.
Our manufacturing process applies strict controls to deliver quality products on schedule. Our facility is certified to ISO 13485 and is compliant with the FDA Quality System Regulation (CFR 820). Regular audits and factory inspections by CSA ensure our quality system operates at the level of performance required to consistently produce high quality products.
Should you choose to complete your pilot or leave your long-term manufacturing with us, you maintain a single point of contact and accountability with a team that knows every detail of your product.
Standalone Manufacturing Services
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 you outgrow our capacity, we’ll help facilitate the transfer to a larger contract manufacturing firm. Contact us to find out more.
Services include:
- prototyping and pre-production
- manufacturing transfer and process documentation
- testing development and documentation
- process validation
- device assembly
- supply chain set-up and management
- ongoing service and support (both at our factory and in the field)