How to create and maintain an ISO 14971-compliant Risk Assessment using other standards

Instructor: Edwin L Bills
Product ID: 700727
  • Duration: 60 Min

recorded version

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Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Mar-2008

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Read Frequently Asked Questions

This presentation will discuss how to use product standards to demonstrate we have reduced the risk to acceptable levels.


This program will be beneficial for those who must complete Risk Assessment activities as part of medical device development.

During Risk Analysis it is our task to identify hazards and evaluate the risk posed by these hazards. We then establish risk control measures as required by our evaluation of the risk. Standards can be used to evaluate our mitigation of the risk.

Areas Covered in the seminar:

  • Use of product standards to demonstrate meeting requirements of the risk management process.

Who will benefit:

This program will be beneficial for those who must complete Risk Assessment activities as part of medical device development including:

  • Design Engineers
  • Quality Engineers
  • Compliance Engineers
  • Manufacturing Engineers
  • Regulatory personnel

Instructor Profile:

Edwin L. Bills, was Industry Co-chair for the AAMI Committee AAMI/QM/WG 04 Application of risk management to medical devices, representing the United States on ISO TC 210 Joint Working Group 1 which developed the ISO 14971 standard. He has served as a Director of Risk Management for major medical device companies. Mr. Bills also presented at a number of conferences on Risk Management topics and has authored articles on the topic as well.

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