Plastics are typically the main materials used in medical devices. Characterization of the relevant properties is key to ensure their quality and performance standards.
Polymer testing of medical devices is integral to product development, improvement, and failure analysis investigations. With an experienced eye on current regulatory specifications, Exova’s highly qualified polymer experts have the knowledge to help you improve and qualify your materials and products.
Our polymer testing techniques and methods include:
- Fourier Transform Infrared (FTIR) Spectroscopy for material identification
- Differential Scanning Calorimetry (DSC) for material thermal properties (Tg, Tm, thermal transitions in protein-based devices, residual cure)
- Thermogravimetric Analysis (TGA) for filler content and deformulation
- Physical testing – Tensile, Compressive, Flexural, Density, Hardness, Melt Flow
- Scanning Electron Microscopy/Energy Dispersive Spectroscopy (SEM/EDS) for morphology and elemental analysis
- X-Ray Diffraction (XRD) for crystal structure of drugs in combination polymer/drug devices
- Gel Permeation Chromatography (GPC) for Molecular Weight (MW) and Molar Mass Distribution (MWD) of polymers
Exova is accredited to ISO/IEC 17025 through A2LA and the Standards Council of Canada and is regularly inspected by the Food and Drug Administration (FDA) and Health Canada. Our polymer scientists are experienced across a range of medical devices, including Class I, II, and III devices.
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1300 First State Blvd, Suite C,
Wilmington, DE 19804
Contact: Waheed Sheikh - President
Tel: +1 302-636-0202
Fax: +1 302-636-0204