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