Medical Devices and Combination Products

• Determine the most relevant testing conditions for your product and write your protocol
• Execute your study within a GMP/GLP/ISO  17025 compliant quality system
• Identify extractable compounds using our proprietary spectral database of over 1,500 non-volatile compounds
• Assess the toxicological risk of identified compounds according to ISO 10993-17 and the latest update to ISO 10993-18 to provide a report that is ready for regulatory submission

• Method Development & Validation
• Stability for Leachables
• Toxicological Risk Assessments
• Biocompatibility Testing

• Agilent LC/MS TOF and QTOF
• Agilent/Waters HPLC/UHPLC – including UV/Vis, RI, Fluorescence, ELSD, CAD, and Conductivity detectors
• Agilent GC/MS – both headspace and direct injection sample introduction
• Agilent GC/FID/TCD – both headspace and direct injection sample introduction
• Agilent ICP/MS and ICP/OES
• Thermo Scientific iCAP ICP-OES
• Perkin Elmer ICP-OES
• Bruker Avance 3 (500 MHz) Liquid NMR
• Bruker Avance 3 (400 MHz) Liquid NMR

Chemical characterization is the first step in the workflow used to establish the biological safety of medical devices, as required by ISO 10993. 

Many compounds are intentionally added during the manufacture of a device, including colorants, plasticizers, impact modifiers, and processing aids. Others may be picked up inadvertently during processing or result from a degradation reaction during sterilization or storage.

Important phases in your product development lifecycle that may require E&L assessments include:

• Developing new product design concepts
• Performing verification testing for your design history file 
• Changing raw material suppliers
• Implementing design or manufacturing process change