ISO 14971:2019 Overview

Understand the requirements of the ISO 14971:2019 standard for the Application of Risk Management to Medical Devices

Course Details

  • Length: 1 day (8am-5pm Central Time)
  • CTUs: 0.8
  • Audience: Organizations and personnel performing risk management planning and maintenance of risk files for medical device and related products. This includes development engineers, process engineers, customer complaint managers, quality and regulatory personnel and the people who supervise them.
    • Describe the ISO 14971:2019 requirements and its relationship to ISO-13485:2016
    • Describe the relationships between medical device design risk and manufacturing process risk
    • Show the relationships between ISO 14971:2019 and ISO / TR 24971:2020
    • Practice FMEA technique on a commonly understood product or process
    • Apply the process approach and Plan-Do-Check-Act (PDCA) methodology to ISO 14971:2019 to keep risk documents updated with new information
    • Learn the relationship between ISO 14971:2019 and A11
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