Medical Device Support

BSSI has successfully supported the development and clearance for numerous medical devices.  Whether it is an in vitro diagnostic or an imaging tool, our staff has deep expertise in analytical and clinical validation, including multiplex assays employing advanced technologies such as NGS. Our strategic consultants help with study conceptualization and design as well as with supporting regulatory communications. Our statistical staff has extensive experience in assay validation and methods comparison from R&D validation, through Laboratory Developed Tests (LDT), 510k (Class I through de novo), and PMA clearances for simple and advanced technologies.

Study Conceptualization and Design

  • Analytical and clinical design considerations
  • Protocol development
  • Power and sample size determination

Statistical Analyses

  • Analytical assay/methodology validation
    • Specificity, accuracy, precision, limits of detection, limits of quantification, linearity and range, ruggedness, robustness, and reproducibility
  • Device comparison
    • Non-inferiority, superiority, equivalence
  • Quality assurance and control
    • Quality management system and processes to support regulatory submissions
    • Statistical packages and software for analysis in a regulated environment

Reporting and Regulatory Communications

  • Experience with many regulatory bodies: CAP, CLIA, ISO, FDA, EMA
  • Comprehensive packages in support of PMA, 510(k) (Class I, II, III and de novo), CE mark, LDT, IDE applications