Specialists in Medical Device Development and Manufacturing

Fully Automated Cell Separator for StemCell Technologies

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Manufacturing Services

We offer a comprehensive turnkey solution for manufacturing medical device products for our clients, from manufacturing transfer through to technical post-sales support and sustaining engineering. StarFish is registered as a manufacturer with Health Canada and the FDA, as well as CSA listed. The manufacturing process is part of our ISO 13485 certified Quality Management System. Strict definition and control of the manufacturing process from supply chain management to final test ensure quality products that are delivered on schedule.

Services include:

Turnkey manufacturing solutions

Product management

Manufacturing transfer

Process validation

Device master record

Device history record

Change control

Lifecycle planning

Manufacturing specifications and procedures

Documentation control

Supply chain

Part sourcing and ordering

Vendor qualification and management

Receiving and incoming inspection

Inventory management

Device assembly

Device calibration and testing

Cleaning

Packaging

Quality control

Equipment control

Finished goods inventory

Bulk packaging, palleting

Finished good shipping logistics

Technical support

Customer service support

Extended warranty

Preventative maintenance programs

Field service

Sustaining engineering support