Study Materials

Harmonizing Medical Device Regulation – Fall 2023

View the Core Curriculum

Session slides & materials
(click title to open .pdf files)

Day 1
Session 2: “What defines a medical device?
Session 3: “Essential Principles of Medical Device Safety
   Session 3 Classification chart
Session 5: “Designing Development Programs under the Essential Principles
Session 6: “Risk Management: Principles and Examples
Session 7: “Environmental and Human Factors

Day 2
Session 1: “Essentials of Conformity Assessment
Session 2: “In Vitro Diagnostic Devices
Session 3: “Audits and the MDSAP program
Session 4: “Principles of Labeling
Session 5: “Auditing Principles


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