Medical Devices

Pace Analytical Life Sciences offers analytical chemistry and physical testing services for the qualitative and quantitative assessment of medical devices. We understand that bringing innovative medical device technology to the global marketplace is a major financial investment and high‐risk venture. That 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.

Pace provides the expertise to perform a wide variety of chemical, physical and microbial tests per FDA, ASTM and ISO medical testing requirements. We can also help develop and validate client-supplied test methods in every stage of medical device development.

For more than a decade, we have successfully helped scientific, engineering and manufacturing companies turn innovative concepts into reliable and safe medical devices. Partnering with Pace Analytical ensures that you have the scientific staff and world-class facilities required to succeed in a competitive, dynamic and highly regulated industry.

Pace Analytical Life Sciences provides the following analytical services to the Medical Device Industry:

Chemical Characterization Supporting Biocompatability
Vendor Change Assessments
ISO 10993-7, Residual Chemical Analysis
ISO 10993-18, Chemical Characterization
Physical Testing
Packaging Headspace Analysis
Extractable/Leachable Testing
Material Characterization
Cleaning Verification and Validation
Headspace Analysis
Molecular Weight Determination of Polymers
Plastic Testing (Aqueous and Non-aqueous extractions), USP <661>
Test of Sterility
Bacterial Endotoxins
Microbial Bioburden

Our experienced microbiologists provide expertise in compendial method testing, method development, method validation and custom research projects.

Pace Analytical Life Sciences distinguishes itself by offering access to new, cutting-edge technologies. Our expertise in rapid microbiology techniques, especially bacterial identification and characterization via ribotyping, is unique in the industry. Pace Analytical Life Sciences will partner with you to select the most appropriate technology, perform feasibility studies for your product and help navigate you through validation and FDA approval.

Microbiology Services

Pace Analytical Life Sciences' Medical Device testing services help our clients ensure that their product has been manufactured, packaged and sterilized in accordance with GMP guidelines.