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ISO 14971 Application of Risk Management to Medical Devices Overview

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Seminar Content

This two-day seminar addresses all of the elements of the ISO 14971:2019 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

  • Explore the specifics of ISO 14971:2019, the Application of risk management to medical devices.
  • Provide a hands-on approach to the medical devices process and its relationship to program deliverables and status reporting.
  • 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 Analysis
    • Risk Identification
  • Risk Analysis Tools
  • FMEA Risk Management
  • Risk Evaluation
  • Risk Control (treatment)
  • Monitoring and Review
  • Summary

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