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ISO 14971 Application of Risk Management to Medical Devices Overview

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Seminar Content

This one-day seminar addresses all of the elements of the ISO 14971: Application of Risk Management to Medical Devices, and defines it as a process within your organization. It provides an overview of the six steps of the Risk Management process and how it is managed as a process.

Who Should Attend

Those who have direct responsibility for introducing new medical devices and/or a new manufacturing processes and systems would benefit from this seminar. This includes: program/product managers, quality managers, design engineers, manufacturing engineers, and others who have direct responsibility for medical devices development and improvement.

Recommended Training and/or Experience

No prior knowledge is necessary. However, a mix of students with knowledge of product design & development and/or manufacturing and basic Quality Assurance concepts is preferred.

Seminar Materials

Each participant will receive a seminar manual and a workbook including all team breakout exercises.

Seminar Goals

  • Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting to provide the competencies needed to introduce new products and processes smoothly with known risks minimized

Seminar Outline

  • Principles for Managing Risk
  • Framework for Managing Risk
  • Process for Managing Risk
    • – Risk Assessment
    • – Risk Identification
    • – Risk Analysis
    • – Risk Evaluation
  • Treatment of Risks
  • Measuring and Reviews
  • Risk Evaluation
  • Risk Treatment
    • – Safety Tactics
  • Monitoring and Review
  • Summary

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