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Day 1
Introduction and Orientation
What Defines a Medical Device?
Principles of Medical Device and IVD Classification
Panel Discussion
Medical Device Safety and Performance + Workshop
Risk Management
Environmental and Human Factors
Day 2
Essentials of Conformity Assessment
In Vitro Diagnostic Devices
Audits and the MDSAP Program
Labeling Guidance based on IMDRF
Auditing Principles & Final Questions
