Design Controls for the Medical Device Industry provides real-world examples, strategies, and templates for the implementation of effective design control programs that meet current ISO 9000 and FDA QSR standards and regulations. It also offers product development models for the production of safe, durable, and cost-efficient medical devices and systems. The book details procedures utilized by leading companies to successfully meet FDA and end-user requirements, manufacture high-quality products, and improve and generate profit. It presents blueprints for the application, evaluation, and refinement of quality assurance and performance practices, from product launch through engineering and assembly.