Medical Devices

LEGEND's Investigative Chemistry Department specializes in supporting the unique analytical chemistry and physical testing needs associated with medical device manufacturing and product development. Experienced chemists manage routine quality control analyses as well as customized developmental and validation study procedures. Comprehensive calibration, verification and validation assure the highest confidence in results to support R&D and regulatory compliance. In doing so, LEGEND complies with FDA and EPA Good Laboratory Practices (GLPs).
  • Extraction Studies ISO - 10993 - Parts 13, 15, 18
  • Infusion Equipment  ISO - 8536 Parts 4, 8, 9
  • Chemical Stability Studies
  • Investigative Problem Solving
  • Failure Analysis
  • Polymer Analyses
  • Thermal Analyses - DSC, TGA, TMA, DMA
  • Particulate Analysis
  • USP Analysis
  • ASTM Testing Protocols
  • Melting Point/Glass Transition Measurements
  • Water Purity Testing
  • Substitute Vendor/Materials Qualifications

View our Instrumentation List