Medical Device Risk Management

• Update your knowledge of the risk requirements in the new MDR
• Gain a comprehensive overview of the global regulatory standards for risk management, including ISO 14971:2012, ISO 13485:2012, EN ISO 62366-1 and critically referenced standards such as EN ISO 10993-1 and ISO 14644
• Develop your skills in risk management planning by practically applying a variety of tools and techniques to case studies
• Learn how to effectively analyse ongoing risk management activities such as PMS and clinical investigations and enhance your understanding of their regulatory procedures.
• Improve your understanding of the regulatory requirements and procedures in a Quality Management System
• Cement your knowledge through group discussions, case studies and interactive exercises

Matthew Theobald

Matthew has over 25 years’ experience working at strategic, site and project levels with organisations across Europe and the US. He has worked in medical device, combination product and pharmaceutical development and Quality Management. Matthew has presented at conferences throughout Europe, delivered more than 70 training events, co-authored two books about Human Factors for Medical Devices, including “How Humans Factor (in medical device design)” and one on project leadership. Matthew is currently the Director of New Product Development at his own Consultancy Firm, Three Circles.

This course will be useful for personnel involved in risk assessment and risk management activities, and for those who need a complete in-depth overview of the medical device regulatory framework for risk management throughout the entire device lifecycle. It will be applicable for professionals in:

• Regulatory affairs
• Quality assurance
• Product managers
• Design engineers
• Clinical staff
• Project managers