Risk Management (ISO 14971:2013)- Overview

Seminar Content

This one-day course will provide an overview/understanding of the ISO 14971:2013 standard and its relationship to a Quality Management System and regulatory requirements for the Medical Devices/IVD Industry.

The running example will be used throughout the five-day Risk Management and Analysis in Medical Device Manufacturing Series. (This also includes:Practical Risk Management using DFMEA and Practical Risk Management using PFMEA).

Who Should Attend

  • Risk Management personnel
  • Quality Managers
  • Technical Managers
  • Regulatory Affairs Managers

Recommended Training and/or Experience

Participants should possess a working knowledge of quality systems and methodologies.

Seminar Materials

Each participant will receive a seminar manual including breakout exercises and related material.

Seminar Goals

  • Understand the key elements required for the management of risk as specified in ISO 14971:2009
  • Understand the relationship between risk management and regulatory requirements.
  • Understand the relationship between risk management and quality management system requirements.
  • Have experience of constructing a risk analysis and risk evaluation in a workshop environment

Seminar Outline

  • Risk Management
  • Managing Risks
  • Risk Analysis