Medical Devices

Client-Focused Testing

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 of Materials (Extractable/Leachable Testing)
  • ISO 10993-7, Ethylene Oxide Sterilization Residuals
  • ISO 10993-5, Tests for In vitro Cytotoxicity
  • ISO 10993-4, In vitro hemocompatability tests
  • ISO 10993-3, In vitro genotoxicity tests
  • Physical Testing
  • Microbial Bioburden
  • Test of Sterility
  • Bacterial Endotoxins

ISO 10993 testing provides the medical device industry with guidance to the analytical testing of both the materials used to make medical devices and the finished devices. The services that we offer are:

  • ISO 10993 Part 18, Chemical Characterization of Materials (ISO Material Characterization) Regulators are requiring companies to provide quantifiable data on the chemical composition of the materials going into their medical devices.  PLS offers industry-leading analytical testing using current and state-of-the-art analytical instrumentation to support this standard.
  • ISO 10993 Part 7 Many medical devices require some form of terminal sterilization and often ethylene oxide is chosen because it is effective and does not adversely affect many of the materials used to make medical devices.  The use of ethylene oxide as a sterilant obligates companies to demonstrate that ethylene oxide (ETO), and its common degradant ethylene chlorohydrin (ECH) and ethylene glycol (EG), are removed from the product and packaging.  PLS offers analytical services for terminally sterilized medical devices using currently accepted Gas Chromatography (GC) methods and has also researched and developed new methods for industry using unique technology to offer better sensitivity and improve data turnaround times over conventional testing methods.

Industry-Standard Methods

Pace Analytical Life Sciences (PLS) provides industry-standard methods and custom analytical chemistry and microbiology services for the testing of medical devices. Our service offerings for the medical device industry are based on industry standards and follow the guidance of ISO, AAMI, ANSI and ASTM documents and methods. The material- and product-specific testing details are defined by custom protocols developed in collaboration with our clients. Our device testing services include chemical characterization, biocompatibility testing, testing to support cleaning validation and plastic analysis ISO 10993 testing.

Download Evaluation of Medical Devices literature.