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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 developemental 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 (GLP).

CONSULTING ANALYSIS
  • FDA Extraction Studies
  • Chemical Stability Studies
  • Investigative Problem Solving
  • Failure Analysis
  • Polymer Analyses
  • Physical Testing DMA,TGA,TMA,DSC (elasticity,viscosity, rheology,degree of cure,etc.)
  • Tensile & Compression Testing
  • Cyclic Testing
  • Permeability Testing
  • Peel Strength and Adhesion Testing
  • Flex Testing
  • Determination of Modulus at Varying Temperatures and Frequencies
  • USP Analysis
  • Surface Tension/Degree of Wetting
  • ASTM Testing Protocols
  • Melting Point/Glass Transition Measurements
  • Water Purity Testing
  • Subsitute Vendor/Materials Qualifications
  • NMR Analysis
  • ISO 10993:18 Characterization of Medical Devices
View our Instrumentation List
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Saint Paul, MN Laboratory

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