Medical Device Forensic Engineering

Did you know that a medical device manufacturer is required by CFR 21 part 820 to keep a detailed record of the design process for every medical device?  This record can provide evidence that your defendant performed an exceptional hazard analysis and designed a safe product, or can provide evidence that your plaintiff was hurt by a poorly thought through, inadequately designed, unsafe product.

Our experts have Class I, II and III medical device design experience, know the rules that medical device manufacturers are governed by, and can assist you in:

  • Inspection and testing of subject and exemplar devices
  • Comparing devices to the standard of care
  • Determining incident cause/liability
  • Discovery requests
  • Analysis of discovery received
  • Finding prior ‘adverse incident’ reports and associating those with or differentiating those from the incident device.
  • Testing and/or evaluating ‘safer alternative designs’