Medical Device

Pace Analytical Life Sciences offers analytical chemistry and physical testing services for the qualitative and quantitative assessment of Medical Devices. We typically follow client-supplied methods, published methods (ISO, ASTM, etc.) or methods that we have developed and validated for our clients. We are set-up to provide full service testing for material characterization which can correlate chemical and physical testing analysis.

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

  • Chemical Analysis Supporting Biocompatability
  • Vendor Changes
  • ISO 10993-7, Residual Chemical Analysis
  • ISO 10993-18, Chemical Characterization
  • Physical Testing
  • Packaging Headspace Analysis
  • Extractable/Leachable Testing
  • Material Characterization
  • Cleaning Validation
  • Headspace Analysis
  • Molecular Weight Determination of Polymers
  • Plastic Testing (Aqueous and Non-aqueous), USP <661>

Our experienced professionals of degreed 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.

 

Contact us to discuss your testing needs.  651-738-2728 Email Us