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.
|Advisor:||Hsu, John C.|
|School:||California State University, Long Beach|
|School Location:||United States -- California|
|Source:||MAI 51/05M(E), Masters Abstracts International|
|Subjects:||Engineering, Industrial engineering, Systems science|
Copyright in each Dissertation and Thesis is retained by the author. All Rights Reserved
The supplemental file or files you are about to download were provided to ProQuest by the author as part of a
dissertation or thesis. The supplemental files are provided "AS IS" without warranty. ProQuest is not responsible for the
content, format or impact on the supplemental file(s) on our system. in some cases, the file type may be unknown or
may be a .exe file. We recommend caution as you open such files.
Copyright of the original materials contained in the supplemental file is retained by the author and your access to the
supplemental files is subject to the ProQuest Terms and Conditions of use.
Depending on the size of the file(s) you are downloading, the system may take some time to download them. Please be