Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.