Medical Devices

Medical Devices, Implants & Surgical Tools [MCE]

Medical device design, development, and regulatory support

Exponent's electrical engineers and computer scientists are experienced in the medical device design process, including design verification, usability studies, electrical medical equipment configuration, software review, and laboratory testing.

How can you accelerate the path to market for innovative new medical devices?

Clear design and development plans are critical for efficient medical device design, but many equipment manufacturers experience major schedule, resource, and expense challenges and fail to make it through validation. Exponent's electrical and biomedical engineers provide engineering expertise early in the medical device product development process and routinely provide the following support:

  • Medical device testing, including accessory components and power management
  • IEC60601 standards implementation and certification process preparedness
  • Medical equipment and system lifecycle management support (including early design)
  • Risk management requirements, such as hazard identification, risk acceptability criteria, and pre- and post-production risk analysis
  • Failure root cause analysis for medical device manufacturers
  • Remediation support with electromagnetic compliance re-qualification

Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.