Medical Devices

At Pace Analytical Life Sciences (PLS), we understand that bringing innovative medical device technology to the global marketplace is a major financial investment and high-risk venture. This is why we strive to provide our clients with comprehensive testing capabilities and reliable test data in a timely manner. From test protocol development and prototype/feasibility trials to product failure analysis and material validation/identification - we help our clients bring compliant and effective medical products to market faster.

PLS provides the expertise to perform a wide variety of chemical, physical and microbial tests meeting the FDA, ASTM and ISO testing requirements. Also we develop and validate custom test methods and implement client-supplied test methods to support every stage of medical device development. Partnering with PLS ensures that you have the scientific staff and world-class facilities required to succeed in a competitive, dynamic and highly regulated industry.

Analytical services include:

  •  ISO 10993-18, Chemical Characterization Supporting Biocompatibility
  •  ISO 10993-7, Residual Chemical Analysis
  •  Extractable/Leachable Testing
  •  Physical Testing/Material Characterization
  •  Cleaning Verification and Validation
  •  Vendor Change Assessments
  •  Polymer Molecular Weight Determination
  •  USP Plastics Testing, USP <661>
  •  Test of Sterility
  •  Bacterial Endotoxins
  •  Microbial Bioburden

Download Evaluation of Medical Devices literature.