Courses

Choose a course and work through the lessons at your own pace.

4lessons1 h 7 minof video
QMSR

FDA's Quality Management System Regulation

21 CFR Part 820 as revised by FDA's 2024 Final Rule, re-presented from FDA's CDRH Learn presentations.

3lessons58 min

  1. Lesson 1: FDA QMSR Overview

    15:25 · 11 chapters · 10 questions
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  2. Lesson 2: Navigating FDA QMSR

    19:42 · 13 chapters · 10 questions
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  3. Lesson 3: QMSR Risk Management and Risk-Based Decisions

    22:36 · 16 chapters · 10 questions
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MDR

Medical Device Reporting

What manufacturers need to recognize, record and escalate under 21 CFR Part 803.

1lesson9 min

  1. Lesson 1: Medical Device Reporting Awareness

    8:55 · 11 chapters · 10 questions
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