Risk Management 1: ISO 14971

Who should attend

This introductory course is of value to employees at all levels within the organization of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Regulatory Affairs professionals
• Quality Assurance professionals involved in design and/or manufacturing
• Design engineering professionals
• Clinical professionals
• Product Management professionals
• Personnel involved in risk assessment and risk management activities

Course Outline

Risk Management is a complex process that is growing in importance for medical device companies with its introduction into a number of recently published medical device standards. ISO 14971 has been written to enable its integration into existing company quality systems and provides a disciplined approach for proactive decision making based on recognised risk and the implementation of strategies to mitigate those risks.

This practical, workshop based course with case studies has been designed to provide delegates with the skill (including tools and techniques) and knowledge required to understand, interpret and apply ISO 14971 as well as the ability to integrate risk management into their existing organisation and Quality Management Systems. The course will focus specifically on the ISO 14971 regulations in relation to the development and implementation of effective risk management lifecycle and will also incorporate the requirements of the Global Harmonization Task Force’s recent guidelines.

Topics covered include

• Overview of ISO 14971 standard and GHTF Guidance “Implementation of Risk Management Principles and Activities within a Quality Management System.”
• Lifecycle of Risk
• Risk Management File & Plan
• Risk Evaluation—Identification of harms, hazards and hazardous situations, tools and techniques including FMEA, Fault Tree Analysis
• Risk Control and Reduction
• Residual Risk Evaluation
• Risk Report including the risk benefit analysis
• Production / Post Production Requirements as part of ongoing Post Market Surveillance activities
• Links to other medical device standards including ISO 10993-1 and IEC 62366 Medical devices
• A solid appreciation of the requirements for risk management
• A comprehensive understanding of ISO 14971 and it’s application
• Ability to enhance existing systems by the integration of risk management
• The ability to use risk management techniques within day to day activities
• Have the skills required to plan, conduct, report and follow-up on risk management activities

Outcomes

• A solid appreciation of the requirements for risk management
• A comprehensive understanding of ISO 14971 and it’s application
• Ability to enhance existing systems by the integration of risk management
• The ability to use risk management techniques within day to day activities
• Have the skills required to plan, conduct, report and follow-up on risk management activities