DAY 1 | 8 AM-5 PM
Introduction to ISO 14971
Basic Terms and Concepts
Risk Management requirements
Risk Management at CDRH
DAY 2 | 8 AM-5 PM
Risk Management in Product realization
· Design Controls
· Risk Management and Usability
· Production and Service provision
· Control of Monitoring and Measuring equipment
Special requirements for Software Risk Management
DAY 3 | 8 AM-5 PM
Overall Residual Risk
Production and Post-Production Information including Medical MDR and IVDR requirements
Managing the risk management file
Risk Management in quality systems than Product realization
FDA and AAMI faculty work together to help the learner understand:
· Basic terms of risk management and how they relate to each other and how to use risk management throughout the quality system to make risk-based decisions for product realization cradle to grave
· How to use a variety of risk management tools to support risk-based thinking and decision making along with typical scenarios when the tools can be most useful,
· FDA's expectations for submissions and compliance, as well as how to apply risk management principles to various aspects of a quality system as required by the FDA and ISO 13485:2016,
· The current state of risk management based on ISO 14971 and other applicable product safety standards including those related to processes and those related to specific medical device products.
· How risk management is audited during MDSAP audits and how that relates to country specific requirements for risk management activities or risk-based decisions.
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. For participants to gain the maximum benefit from this course, it is recommended for those who have a working knowledge of the Quality System regulation and design controls or who have already attended AAMI's Quality System and Design Control courses.
Learning objectives are delivered in a highly interactive format includes relevant examples from a broad product spectrum that demonstrate current industry practices of risk management throughout the quality system and product life cycle. In addition, interactive, hands on exercises will allow participants to practice applying risk management concepts, principles, and tools throughout the product life cycle and the quality system.
Fee includes a comprehensive eNotebook of all training materials and many of the referenced materials, including FDA and Global Harmonization Task Force, and IMDRF guidance documents relevant to the course, all in one easy to find and download location. Also provided is ANSI/AAMI/ISO 14971:2007/(R) 2010, Medical devices - Application of risk management to medical devices