About the Course

Join us in mastering ISO/TR 24971:2020 and revolutionize your approach to medical device risk management. Addressing the challenges directly, this course equips you with the knowledge and skills to ensure compliance and enhance safety in medical device development. Take the first step towards a successful career in the medical device industry today!

Course Curriculum

6 Chapters · 24 Lessons

  1. 1

    Introduction to ISO 14971

    1. (Included in full purchase)

      Overview of ISO 14971:2019

    2. (Included in full purchase)

      Understanding ISO/TR 24971:2020

    3. (Included in full purchase)

      Briefing Document: ISO 14971:2019 and ISO/TR 24971:2020 - Medical Device Risk Management

    4. (Included in full purchase)

      ISO 14971:2019 and ISO/TR 24971:2020 Study Guide

  2. 2

    Establishing a Risk Management Framework

    1. (Included in full purchase)

      Risk Management Planning

    2. (Included in full purchase)

      Risk Assessment Techniques

    3. (Included in full purchase)

      Briefing Document: Medical Device Risk Management

    4. (Included in full purchase)

      Medical Device Risk Management Study Guide

  3. 3

    Implementing Risk Control Measures

    1. (Included in full purchase)

      Identifying Control Measures

    2. (Included in full purchase)

      Monitoring and Review of Controls

    3. (Included in full purchase)

      Briefing Document: Risk Management for Medical Devices

    4. (Included in full purchase)

      Risk Control and Monitoring in Medical Device Manufacturing

  4. 4

    Communication and Documentation

    1. (Included in full purchase)

      Effective Risk Communication

    2. (Included in full purchase)

      Documentation Best Practices

    3. (Included in full purchase)

      Briefing Document: Risk Communication and Documentation in Medical Device Manufacturing

    4. (Included in full purchase)

      Medical Device Risk Management Study Guide

  5. 5

    Continuous Improvement in Risk Management

    1. (Included in full purchase)

      Feedback Mechanisms

    2. (Included in full purchase)

      Adapting to Regulatory Changes

    3. (Included in full purchase)

      Briefing Document: Risk Management in Medical Devices - Feedback & Regulatory Updates

    4. (Included in full purchase)

      Medical Device Risk Management: A Study Guide

  6. 6

    ISO/TR 24971:2020

    1. (Included in full purchase)

      ISO-TR-24971-2020

    2. (Included in full purchase)

      Briefing Document: ISO TR 24971:2020 Guidance on Medical Device Risk Management

    3. (Included in full purchase)

      Medical Device Risk Management Study Guide

    4. (Included in full purchase)

      ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971

Ready to Master Risk Management?

Enroll now to gain the knowledge and skills needed to excel in medical device development.

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