Exponent consultants often assist clients with their device design verification and validation process. Clear design and development plans and well-defined design inputs are essential to an efficient design process. However, many devices fail to make it through the validation stage, when product design changes may have major schedule, resource, and expense ramifications that could impact project success. Exponent engineers are highly experienced in all aspects of the device design procedure, including areas such as design verification, device usability studies, electrical medical equipment configuration, and laboratory testing.
Our electrical and biomedical engineers provide engineering expertise early in the medical device product development process. We have routinely provided services related to areas such as:
- The testing of medical devices, accessory components, and power management (e.g., Lithium battery packs).
- Support to ME equipment manufacturers in implementing IEC60601 standards and preparing for an efficient and effective certification process.
- Support in all phases of ME equipment and system life-cycle, including early design assistance.
- Establishing general requirements for risk management, such as hazard identification, risk acceptability criteria, as well as pre- and post-production risk analysis.
- Assistance to medical device manufacturers in determining the root-cause of failures.
- Support in remediation activities to correct deficiencies and guidance through electromagnetic compliance (EMC) re-qualification of their products.