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ISO 14971:2019
Risk Management for Medical Devices

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Course Overview
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  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

 

  • Target Audience: Quality engineers, regulatory affairs professionals, design teams

 

  • Certificate: Professional Development Certificate of Completion

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Learning Outcomes

Upon completion, participants will be able to:

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  • Implement comprehensive risk management systems

  • Conduct effective risk analysis and evaluation

  • Develop risk control measures and verification

  • Integrate risk management with quality systems

Module 1:
Risk Management Fundamentals
(2 hours)

  • Risk management process overview

  • Risk management planning and policy

  • Risk management file structure

  • Hazard identification techniques

  • Homework: Risk management plan development for case study device

Module 2:
Risk Analysis and Evaluation
(2 hours)

  • Risk analysis methodologies (FMEA etc.)

  • Probability and severity estimation

  • Risk evaluation criteria development

  • Risk acceptability determination

  • Homework: Risk analysis exercise using provided device scenario

Module 3:
Risk Control and Verification
(2 hours)

  • Risk control option selection

  • Implementation of risk control measures

  • Residual risk evaluation

  • Risk-benefit analysis

  • Homework: Risk control measure development and verification planning

Module 4:
Post-Market Risk Management
(2 hours)

  • Production and post-production information

  • Risk management review and updates

  • Risk management report preparation

  • Integration with post-market surveillance

  • Homework: Post-market risk monitoring procedure development

If you are interested in booking onto our next online course, please get in touch with us to discuss the next available dates.
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