Lesson outline

  • 01

    Lesson introduction

    • L4 0 ISO 14971, risk management process, and agile - introduction
  • 02

    ISO 14971, risk management process, and agile

  • 03

    Risk analysis and evaluation

    • L4 2 Risk analysis and evaluation (video)

    • L4 2 Risk analysis and evaluation (slides)

    • L4 2 Risk analysis and evaluation (quiz)
  • 04

    Risk controls

    • L4 3 Risk controls (video)

    • L4 3 Risk controls (slides)

    • L4 3 Risk controls (quiz)
  • 05

    Residual risks and benefit-risk analysis

    • L4 4 Residual risks and benefit-risk analysis (video)

    • L4 4 Residual risks and benefit-risk analysis (slides)

    • L4 4 Residual risks and benefit-risk analysis (quiz)
  • 06

    Lesson takeaways

    • L4 9 Risk management and agile development in line with ISO 14971 - takeaways (slides)

By the end of this lesson, you'll be ...

LEARNING OUTCOMES

  • Understanding the full context

    Including both compliance and agile processes

  • Familiar with regulatory standards

    With insights how FDA and others deal with agility

  • Aware of regulatory challenges

    With key points to address when applying agile

What's included

  • 5 videos with introduction and expert instruction

  • 5 quizzes / assignments

  • Virtual sticky notes with takeaways

  • Social community and lesson discussions

  • Lesson toolbox with learning resources and freebies

  • Digital lesson completion badge

Meet your facilitator

Hey I'm Bruce, an Agile Way of Working coach and trainer from The Netherlands. I have helped 200+ organizations with transformational change and learning to unleash value, flow, agility and people's potential. My background includes an MSc in Engineering, a track record at Microsoft and a SAFe SPC6 certification. Enjoy real-world learning experiences in these lessons!

Bruce Schoor

Agile Way of Working Coach

Lesson outline

  • 01

    Lesson introduction

    • L4 0 ISO 14971, risk management process, and agile - introduction
  • 02

    ISO 14971, risk management process, and agile

  • 03

    Risk analysis and evaluation

    • L4 2 Risk analysis and evaluation (video)

    • L4 2 Risk analysis and evaluation (slides)

    • L4 2 Risk analysis and evaluation (quiz)
  • 04

    Risk controls

    • L4 3 Risk controls (video)

    • L4 3 Risk controls (slides)

    • L4 3 Risk controls (quiz)
  • 05

    Residual risks and benefit-risk analysis

    • L4 4 Residual risks and benefit-risk analysis (video)

    • L4 4 Residual risks and benefit-risk analysis (slides)

    • L4 4 Residual risks and benefit-risk analysis (quiz)
  • 06

    Lesson takeaways

    • L4 9 Risk management and agile development in line with ISO 14971 - takeaways (slides)

Suggested to learn before

LEARNING PATH

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What people say

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FAQ

  • What to do if I have questions?

    You'll be able to post and discuss your question in the built-in community discussion forums. For any questions before you buy, you can contact us at [email protected].

  • How long do I have access to the lesson?

    You receive lifelong access so that you can learn at your own pace. And after you complete the lesson, you'll be able to come back and review all content at any point.

  • Do I receive a certification?

    You receive a Digital Lesson Completion Badge upon finishing the lesson. For courses (collections of lessons), we issue Agile Professional Certifications.

Suggested to learn after

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