Risk Dice - 250 x 250 (Transparent)Understanding ISO 14971:2019 Requirements

Live Remote Training

Description

8 hours of live, instructor-led remote training on the ISO 14971:2019 requirements for the application of risk management to medical devices.  Participants will review the ISO 14971:2019 requirements in detail, explore some of the key concepts related to risk, and walk through the specific steps required by ISO 14971′s risk management process.

Format

Live, instructor-led remote training.

Duration

8 hours (2 x 4 hour sessions)

Technical/System Requirements for Participants
  • Windows 7 – Windows 10 (Microsoft), OR
  • Mac OS X 10.9 (Mavericks) – macOS Mojave 10.14
  • Google Chrome or Mozilla Firefox browser required for breakout activities
  • Internet connection of 1 Mbps or better (broadband recommended)
  • JavaScript enabled
  • Microphone and speakers if using computer audio (USB headset recommended but not required)
  • Telephone if using available long-distance # for audio
  • Webcam optional
Course Outline
  • Introduction to ISO 14971:2019 – Application of Risk Management to Medical Devices
  • ISO 14971:2019 – Scope, Normative References, Terms and Definitions
  • ISO 14971:2019 – Section 4: General Requirements
  • ISO 14971:2019 – Section 5: Risk Analysis
  • ISO 14971:2019 – Section 6: Risk Evaluation
  • ISO 14971:2019 – Section 7: Risk Control
  • ISO 14971:2019 – Section 8: Evaluation of Overall Risk
  • ISO 14971:2019 – Section 9: Risk Management Review
  • ISO 14971:2019 – Section 10: Production and Post-Production Activities
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Course Dates and Registration
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