Our industry experts explain FDA's Medical Device Quality System Regulation and what it means to your organization. Learn what compliance with this regulation means, current trends toward harmonization and implementation strategies, the primary impact of the regulation on medical device companies, and how to comply with the requirements. Understand how the regulation compares with ISO 9001 quality system requirements, what FDA inspectors look for on establishment inspections, and how design control, process validation, supplier evaluation, and risk management fit into FDA's Medical Device Quality System Regulation. Discussions include the impact of ISO 9001 and ISO 13485 on the Quality System Regulation and the medical device industry, and the role of the FDA and international standards bodies.