Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues. 

How Smithers can help

Smithers' knowledge and understanding of polymer material science, together with our testing and regulatory expertise help us provide specialist support for developers of implantable devices.

Our focus is on the performance of plastic and rubber materials in your device together with extractable and leachable considerations - for mechanical implants and combination products where drug delivery is required. We also support sterile packaging requirements and safe transit of fragile devices.

  • Materials: Expert support with selection, characterization and compatibility
  • Compliance: Testing to help you demonstrate regulatory with FDA, MHRA, EMA, USP and ISO as well as BPOG and PQRI guidelines.
  • Extractables and Leachables: extensive expertize in controlled extraction studies, identification of extractables and leachable profile assessments.
  • Device Testing: From testing container closure to connection compatibility, we test devices to ensure they perform as designed and meet relevant regulations.
  • Transit studies: Simulated distribution testing to recreate supply chain condition faced by your device.
  • Product simulation studies: Combination of testing studies to simuate real life usage of your device and the impact this might have on patient safety through its lifetime.
Implantables