Our Services

Manufacturing

Choose a service:

NPI and complex medical device manufacturing

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.

Services include:

prototyping and pre-production
manufacturing transfer and process documentation
testing development and documentation
process validation
device assembly
FDA registered manufacturing facility
class 100,000 clean room (capabilities up to class 10,000)
certified Class 100 Laminar Flow Hoods
supply chain set-up and management
ongoing service and support (both Depot Repair and Field Service)

Our experience was excellent. StarFish always had an answer.

StarFish Medical helped us solve our production line challenges enabling us to deliver products in a timely manner, consistently around the world. We liked that the StarFish solution was future-proof, poising us for growth.

We were looking for people who could speak our language in terms of technical aspects, yet be flexible enough to adapt to our system as it changes over time. We’re used to shifting gears quickly so we wanted a partner that could shift as easily when we make a decision.

The StarFish team are very responsive and responsible individuals with a good work ethic-- they are trustworthy and helpful.

Alex Théoret
Director of Production
Zengar Institute Inc.

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