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
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