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

Richard Young
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. He has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited

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