Qualifications

Presentation

This course provides participants with fundamental knowledge and practical understanding of Risk Management principles based on ISO 14971:2019. Participants will learn the concepts, terminology, risk management processes, responsibilities, documentation requirements, and implementation approaches for product and process risk management, including post-market activities and corrective/preventive actions.

Whom the course is for

• Quality Assurance / Quality Control Personnel
• Regulatory Affairs Personnel
• Production and Engineering Teams
• Risk Management Team Members
• Internal Auditors
• Management Representatives
• Personnel involved in Medical Device Quality Management Systems

Objectives

Upon completion of this course, participants will be able to:

• Understand the principles and concepts of risk management
• Interpret key terms and definitions in ISO 14971:2019
• Understand the risk management process and lifecycle
• Identify management responsibilities in risk management activities
• Develop and implement a risk management plan
• Understand risk management documentation and record control requirements
• Apply product and process risk management concepts
• Conduct basic risk assessment and risk control activities
• Understand post-market monitoring and CAPA concepts

Course Contents