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Meeting Risk Management Compliance Expectations for the 3rd Edition of IEC 60601-1


Description

This one-day workshop gives medical device manufacturers a practical view of the process for documenting required ISO 14971 Risk Management file elements and clarifies information needed to support 3rd Edition Certifications.  Participants will evaluate a fictional manufacturer’s Risk Management file for compliance with IEC 60601-1 by verifying the required documentation, completing applicable sections of the test report form (TRF) and finding the best way to document information through lessons learned. All clause references will be to ISO 14971:2000 unless noted. 

Each participant will receive a copy of the guideline document designed by the IEC Risk Management Task Force.

It is recommended that participants bring a copy of the IEC 60601-1, 3rd Edition and ISO 14971 Risk Management standards.

 

Workshop Topics

  • Determination of applicable requirement and implementation dates
  • General certification methodology and process
  • Highlights of concepts in ISO 14971 that are applied in IEC 60601-1, including:
    • Risk acceptability criteria
    • Risk acceptability process
    • Risk analysis process
    • Risk control hierarchy
    • Risk benefit analysis
    • Collateral risks from risk control measures
  • New concepts introduced in the 3rd Edition of IEC 60601-1, including:
    • Essential performance
    • Expected service life
    • Equivalent safety
    • Medical  parts/equipment that contact patients
    • Fault conditions
    • High integrity components
  • Practical applications, including:
    • Combined 2nd and 3rd edition certifications
    • Power supplies
    • Direct clause interpretation

 

Objectives

  • Determine the applicable medical equipment requirements to design products for compliance
  • Identify expectations and objective evidence needed to support certification
  • Recognize and apply new concepts from ISO 14971
  • Recognize and apply new concepts from IEC 60601-1
  • Explain practical applications for specific situations

Target Audience

  • Product safety engineers
  • Compliance engineers
  • Product designers
  • Production support engineers
  • Quality assurance staff
  • Technical marketing professionals
  • Regulatory affairs staff

Recommended and Related Training

Continuing Education Units (CEUs)

  • 0.7 IACET CEUs; contact your local jurisdiction for CEU recognition.
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Media

Time Requirement

Cost

Instructor-Led 1 day $950.00

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