Services
Manufacturing
Medical Device Production and New Product Introduction
Our facility specializes in the production of low to medium volume electromechanical medical devices. In addition we do pilot production for new product introduction for higher volumes.
From supply chain management, through assembly, to final test, 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).
We manufacture or have manufactured medical devices for sale in Canada, the USA, the EU and the Far East. 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.
StarFish manufacturing 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
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 for medical applications and a network of machining, tooling and fabrication partners allow StarFish to effectively manage and execute any high-precision, short run medical device manufacturing you require. Should you outgrow our capacity, we can help facilitate the transfer to one of the larger contract manufacturers we partner with.
Get started
Contact StarFish and find out how we can help you successfully manufacture your medical device.
