About the Course

Join our course to master ISO 14971:2019, the definitive guide to managing risks in medical devices. From hazard identification to control implementation, equip yourself with the knowledge to ensure product safety and regulatory compliance. Take the first step towards becoming a risk management expert in the medical device industry today!

Course Curriculum

5 Chapters · 20 Lessons

  1. 1

    Introduction to ISO 14971:2019

    1. (Included in full purchase)

      Understanding Risk Management in Medical Devices

    2. (Included in full purchase)

      Scope and Application of ISO 14971

    3. (Included in full purchase)

      Briefing Document: ISO 14971:2019 - Risk Management for Medical Devices

    4. (Included in full purchase)

      Medical Device Risk Management Study Guide

  2. 2

    Identifying Hazards and Risks

    1. (Included in full purchase)

      Hazard Identification Techniques

    2. (Included in full purchase)

      Risk Estimation and Evaluation

    3. (Included in full purchase)

      Briefing Document: Risk Management of Medical Devices under ISO 14971:2019

    4. (Included in full purchase)

      Medical Device Risk Management: A Study Guide

  3. 3

    Risk Control and Mitigation Strategies

    1. (Included in full purchase)

      Implementing Risk Control Measures

    2. (Included in full purchase)

      Monitoring and Reviewing Risk Controls

    3. (Included in full purchase)

      Briefing Document: ISO 14971:2019 Risk Control for Medical Devices

    4. (Included in full purchase)

      ISO 14971:2019 Risk Control Study Guide

  4. 4

    Integrating Risk Management into Quality Systems

    1. (Included in full purchase)

      Aligning Risk Management with Quality Management

    2. (Included in full purchase)

      Case Studies: Successful Integrations

    3. (Included in full purchase)

      Briefing Document: ISO 14971 - Risk Management for Medical Devices

    4. (Included in full purchase)

      ISO 14971 & Risk Management in Medical Device Manufacturing: A Study Guide

  5. 5

    Best Practices and Future Trends

    1. (Included in full purchase)

      Establishing Acceptable Risk Criteria

    2. (Included in full purchase)

      Emerging Trends in Medical Device Risk Management

    3. (Included in full purchase)

      Briefing Document: Risk Management for Medical Devices (Based on ISO 14971 and Future Trends)

    4. (Included in full purchase)

      Medical Device Risk Management: A Study Guide

Ready to Master Risk Management?

Start your journey towards becoming a certified expert in medical device risk management today! Enroll now to gain valuable insights, practical skills, and industry recognition.

Contact Us for Access (opens email in new window)