Module 15 Presentations
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Table of contents
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Module 15 Cover
1
Lecture 1: Current status of the EU Medical Device Regulation
5
Module 15 Agenda
2
Lecture 2: The Clinical Evaluation Process
24
Lecture 3: The Place of Clinical Evaluation
50
Lecture 4: The Notified Body Perspective on Clinical Evaluation
60
Lecture 5: The Summary of Safety and Clinical Performance
70
Lecture 6: The relationship between clinical evaluation and post market surveillance
88
Lecture 7: The Equivalence Assessment under MDR
105
Lecture 8: Clinical Investigations under MDR
127
Lecture 9: Clinical Global Strategy Requirements
154
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