Curtis Egan is an expert in the field of medical and pharmaceutical system, device, clean room validation and safety risk management. He has supported over two hundred medical device and pharmaceutical validation projects. Curtis has been recognized for his ability to achieve difficult goals and timelines while maintaining quality and regulatory integrity of the project and final documentation packages.
Curtis has over 14 years of quality system and validation experience in a variety of technical and management roles. This includes software validation with specialization in the development of test methods and documentation as well as leadership roles establishing standardized software validation including life-cycle processes and implementing formal independent test engineering groups throughout those life-cycles. Curtis is also experienced in facility and utility qualification, providing support for several Fortune 500 medical device companies, ensuring quality and performance of ISO classified cleanrooms and support utilities.
Curtis has also authored a range of FDA & ISO compliant quality system procedures for the FDA QSR, ISO 13485 and ISO 14644. He has extensive experience in performing compliance audits, gap analyses, and implementing best practices for achieving FDA design control compliance.