Chemical Testing & Analysis

EAG Life Sciences can support your medical device development through our staff's extensive analytical chemistry expertise and knowledge of the medical device development process. Our laboratory is outfitted to handle the unique demands of medical device development including novel drug-device combination products. We can assist your company from material selection through quality control testing of finished products. Our facility is also FDA registered and can support your PMA or 510(k) regulatory filing.

Medical Device Chemical Testing Services:

• Material and Chemical Characterization
• Extractables and Leachables
• Migration Studies
• Identification and Quantitation of Potential Degradants and Degradation Products
• Method Development and Validation
• Chemical and Physiochemical Properties
• Forced Degradation and Stability Studies
• Drug-Device Compatibility Studies
• Residual Solvent Determination
• ISO 10993 Testing
• ASTM and Compendial Testing
• Surface Analysis
• Bioanalysis Supporting Preclinical and Clinical Trials
• Material Equivalence to Predicate Device

Medical Device - Chemical Analysis Techniques

Gas Chromatography (GC)

• Flame Ionization Detection (FID)
• Thermal Conductivity Detection (TCD)
• Mass Spectrometry (MS)

Liquid Chromatography (LC)

• Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS)
• Spectrophotometric (UV-Vis)
• Refractive Index (RI)
• Evaporative Light Scattering (ELSD)
• Electrospray Ionization-Ion Trap Mass Spectrometry (ESI-IT-MS)
• Atmospheric Pressure Chemical Ionization-Ion Trap Mass Spectrometry (APCI-IT-MS)

Gel Permeation Chromatography (GPC)
Ion Chromatography (IC)

Molecular Spectroscopy

• Ultraviolet-Visible Spectrophotometry (UV-Vis)
• Fourier Transform Infrared Spectroscopy (FTIR)
• Raman Spectroscopy
• Nuclear Magnetic Resonance Spectroscopy (NMR)

Atomic Spectroscopy

• Inductively Coupled Plasma/Optical Emission Spectroscopy (ICP/OES)
• Flame Atomic Emission Spectroscopy (Flame AES)
• Cold Vapor Atomic Absorption (CVAA)

Microscopy and Surface Analysis

• Optical Microscopy
• Scanning Electron Microscopy/Energy Dispersive X-ray Analysis (SEM/EDS)
• Fourier Transform Infrared (FTIR)
• Raman Microscopy