Singapore Lab Diagnostics Case Study

New Product Introduction & Production Process Validation,


While Designs were Finalized

A tier one medical diagnostics company needed to outsource the new product introduction (pre-FDA clearance) and manufacturing for three newly designed clinical diagnostic systems used in hematology and immunoassay analysis.

To meet their market launch date, the project had to start before the designs were finalized. In only 9 months, Sanmina validated production and shipped the first systems.

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How Sanmina successfully started up production and passed an FDA audit with zero 483s.
This required:

  • 100 hours of assembly and test per instrument using 3,000 components
  • Electronic, fluidics, pneumatics and motion control technologies
  • Customized electronic Device History Record
  • A Master Validation Plan
  • Functional testing using human blood and reagents

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