This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.
• Intensive 3 day program
• Recently updated to reflect the new revision of ISO 14971
• World Class Faculty
• Course developed by FDA and Quality System experts
Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams.
Understand FDA’s expectations for submissions and compliance
Learn how to apply risk management principles to various aspects of a quality system.
Know the appropriate tools for risk evaluation