FAQ

  • How do I go through a lesson?

    After the lesson introduction video, you can go topic-by-topic. For each topic, choose either the video or the slides, followed by a quiz. At the end of the lesson, you find takeaways and resources.

  • What if I have a question or discussion point?

    Inside any learning item, you can click the Discussion button and post a question or discussion point.

  • Where could I learn more?

    At the end of each lesson you find resources with links for further study. For agile topics, you can find more lessons in the agileXL Academy learning library.

Lesson outline

  • 01

    Lesson introduction

    • L1 0 FDA regulatory context for medical devices - introduction (video)

  • 02

    The FDA and medical devices

    • L1 1 FDA goals for medical devices (video)

    • L1 1 FDA goals for medical devices (slides)

    • L1 1 FDA's goals for regulating medical devices (quiz)

  • 03

    Classes and controls

    • L1 2 Classes and controls (video)

    • L1 2 Classes and controls (slides)

    • L1 2 Classes and controls (quiz)

  • 04

    Standards and guidances

    • L1 3 Relevant standards and guidances (video)

    • L1 3 Relevant standards and guidances (slides)

    • L1 3 Relevant standards and guidances (quiz)

  • 05

    FDA's way of thinking and Invisalign

    • L1 4 FDA's way of thinking and Invisalign (video)

    • L1 4 FDA's way of thinking and Invisalign (slides)

    • L1 4 FDA's way of thinking (quiz)

  • 06

    FDA and agile

    • L1 5 The FDA and agile (video)

    • L1 5 The FDA and agile (slides)

    • L1 5 The FDA and agile (quiz)

  • 07

    Lesson takeaways

    • L1 9 FDA regulatory context for medical devices - takeaways (slides)

  • 08

    Resources

    • Resources