This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design control program that not only satisfies the US FDA Quality Systems Regulation (QSR) and ISO 9001:2015 and 13485:2016 standards, but also meets today's Notified Body auditors' and FDA investigators' expectations. Areas addressed are design planning, input, output, review, verification, validation, change, transfer and history. The FDA Quality System Inspection Technique (QSIT) is also covered in-depth.