The safety, performance and durability of medical devices depends upon strict design control and comprehensive quality systems, as outlined in ISO/DIS 13485 and FDA regulations. A successful process development process depends upon reliable definition of user needs, design input requirements, design verification and device validation. Additionally, concurrent engineering approaches, involving production and service staff, help to insure the manufacturability and performance of the device. Our advanced engineering, modeling and simulation capabilities facilitate these design controls; reducing the time and cost of design and development, improving the reliability and safety of the device, and reducing risk.

Gatekey℠ provides advanced engineering services throughout the design, development and manufacturing phases of medical devices, and provides evaluation of inadequacies if they occur.

Services we Provide:

  • Product design and development assistance
  • Design Review
  • Design input requirement review
  • Product Specification review
  • Design verification
  • Concurrent engineering
  • Determining operating windows and robustness of the device
  • Modeling of solids, liquids and interfaces
  • Materials selection and testing
  • Analysis of implanted devices for fatigue performance
  • Failure analysis
  • Forensic services and court appearances


Several of our engineers have been involved in these types of projects:

  • Simulation of Fluid Flow and Stress Analysis of Drug Delivery Devices
  • Fatigue Testing of Medical Device Components
  • Analysis of Implanted Medical Devices for Fatigue Performance