Medical Device Risk Management: Understand and Interpret Key Regulations and Standards

Summary

This 3-half-day course covers all required elements of ISO 14971. You will be able to identify links between standards and regulatory requirements as well as gain tools for risk management. The course is ideal for anyone in a quality, regulatory affairs, engineering or manufacturing.

Our course is based upon worked examples facilitated by the tutor but also enables participants to discuss their products (without breaching intellectual property restrictions!)

Learning Objectives

• Understand, and interpret key regulatory requirements and standards for risk management:
  • EU MDR
  • FDA 21 CFR
  • ISO 14971
• Recognize risk management definitions and principles
• Identify how risk management affects quality management system practices
• Identify the links between ISO 14971, MDR 2017/745 and IVDR 2017/746
• Outline the stages of the risk management process
• Define the key deliverables of the risk management process
• Apply risk management principles within your organization

Key Topics

• ISO14971, EU MDR/IVDR, and US FDA
• Risk Analysis, Evaluation & Control
• The Risk Management File
• Regulatory & Notified Body Expectations
• Post-market and Risk Management\
• Benefit/Risk & Residual Risk Analyses

Who should attend?

This course is suitable for all those involved in:

• Quality
• Regulatory
• Engineering
• Product Development
• Manufacturing

Our online training experience includes

• Our client zone – a single source for all training materials as well as pre and post-training communication
• Live interactive format via the Zoom platform
• Direct interaction with the trainer
• Q&As, case studies, polls
• Revisit recorded sessions for 7 days
• Training in digital format
• Digital and LinkedIn certificates