Course Overview
1 Introduction
2 Safety & Effectiveness
3 Regulatory Pathways
Video
Slides
Quiz
Worksheet
References
5 Quality Systems
6 Intl Regulation
References
Glossary
Summary
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What you will learn in this section
- Formal Requirements
- Institutional Review Board (IRB) Approval
- Informed Consent
- Investigational Device Exemption (IDE)
- Clinical Trials and Study Design
- Important Success Factors
- Case Study: Medtronic VALOR Study to test TALENT Thoracic Stent Graft
- Risk Analysis
- ISO 14971
Content
Play video
- Jan Pietzsch on Clinical Trials and Outcome Measures
- Todd Brinton on Clinical Trials
for Medtech
Slides (PDF)
Speaker's Biographies
Jan Pietzsch
Todd
Brinton
Additional Materials
Assessment Quiz
Worksheet
(pdf)
References (doc)
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