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Product Development

Our scientists and engineers have brought over 50 medical products to the market and have overcome more obstacles than we can count. We can focus that experience on your technology and help your development stay on track.

Design and integration of devices, reagents, controls, packaging, instrumentation, software
Experiment design to establish product technical performance
SOP and test protocols, data capture systems
Data analysis, statistical validation
Reports to support product labeling claims
Product Design verification protocols, analyses and reports
Product types:
  • Biologics
  • Vaccines
  • Cell based therapies
  • Medical devices and diagnostics, Class I - III (EU GHTF Class A-D)
  • Analyte-specific reagents [ASR]
  • Research-use-only reagents [RUO]