Achieving product success in the marketplace depends heavily on product design. Corgenix Reasearch & Development teams work closely with our partners to provide expertise at every stage. From the proof-of-concept or feasibility meetings through technology transfer and into routine manufacturing, our experience in manufacturing, quality control, and regulation ensure the efficient development and seamless transfer of a well-designed product.

Corgenix product development expertise includes:

  • Phase-based Design Control for compliance with ISO13485:2003 and FDA requirements for IVD devices
  • FDA registered¬†and ISO certified facility
  • Continuity throughout the production process, all of which can be handled in our facility
  • Quality System
  • Postmarket technical and product support
  • Audit support

 Corgenix product development capabilities include:

  • A broad range of platforms
  • A full range of regulatory services, including assistance with filings
  • Companion Diagnostics
  • Custom reagent development
  • Development, manufacture, and/or sourcing of raw materials
  • Analytical performance testing and stability studies
  • Assistance with clinical studies and clinical sites
  • Custom packaging and labeling development
  • Critical reagent migration across platforms

Partnering with Corgenix ensures that your product is developed with the success of the customer in mind.