Medical Devices

Product Characterization and Reference Standards

Understanding your product is of paramount importance. Regulators require it, investors demand it, and it can mean the world to your patients. Getting this testing right is critical throughout the development cycle. We have helped clients on a number of important projects, including:

  • Development, oversight, and review of protocols and assessments related to the product characterization efforts, including experimental design and data analysis
  • Development of strategy for identifying and producing appropriate reference standard
  • Development of strategies for long-term management of the reference standard or other critical reagents
  • Composing and reviewing protocols for characterizing the reference standard