Integrating Risk Management into the Product Life Cycle

  • 09 Mar - 11 Mar 2020
  • Royal Marine Hotel & Spa in South Dublin.
  • Dublin / Ireland

 

This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course covers the use of risk management principles throughout the life cycle of the product, from design…to manufacturing…through post-production to retirement. Instructors will illustrate linkages between the product risk management process and quality system processes.Students will discover how to use regulatory databases to support risk management activities at different stages of the product life cycle, as well as the use of International Product Safety Standards during risk management activities.

• Intensive 3 day program

• Recently updated to reflect the new revision of ISO 14971

• World Class Faculty

• Course developed by FDA and Quality System experts

Instruction is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams.

Understand FDA’s expectations for submissions and compliance

Learn how to apply risk management principles to various aspects of a quality system.

Know the appropriate tools for risk evaluation

  • Introduction to ISO 14971
  • Basic Terms and Concepts
  • Risk Management requirements
  • Management Responsibilities
  • Risk Management at CDRH
  • Risk Management in Product realization
  • Design Controls
  • Risk Management and Usability
  • Production and Service provision
  • Control of Monitoring and Measuring equipment
  • Special requirements for Software Risk Management
  • Overall Residual Risk
  • Production and Post-Production Information including Medical MDR and IVDR requirements
  • Managing the risk management file
  • Risk Management in quality systems than Product realization


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Standard Ticket

€2495
  • Full-access to all sessions
  • Free wifi at the conference
  • Conference plus lunch, coffee/snacks
Register