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
