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“
