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Course Details
Overview
John Richard Holborow, Global Head of Clinical Compliance, as he talks about claiming equivalence under the MDR and regulatory considerations
Key Lessons and Takeaway
Topics covered in this presentation:
- MDR Requirements
- General Principles of Equivalence under MDR
- Regulatory aspects of Equivalence based on classification
- Clinical data for Equivalent devices
- Similar Devices
- Technical, Biological & Clinical Aspects
- Questions
Presenter Information
Richard Holborow, Head of Clinical Compliance
