| The design and development process of medical devices in the United States is governed by Food and Drug Administration (FDA) regulations, documented in Quality System Regulation (QSR) 21CFR820. Although QSR lists the documentation requirements for different development stages, it does not specify methods to conduct the processes or to maintain the traceability from the requirements to the final product. Systems engineering approaches such as requirements and functional analyses, design synthesis, implementation, integration, verification, validation, risk management, and technical reviews are used in this thesis to streamline the seven most important stages of the design control process for medical devices (design and development planning, design input, design output, design verification, design validation, design transfer and design review) based on QSR guidelines. The goal is to use systems engineering process to define activities and procedures for increasing efficiency and effectiveness of medical device development, while automatically complying with the QSR requirements. |
