Course Area
Availability
Available for 90 days after enrollment
Approximate Course Run Time
1 hour
Continuing Education Units
0.1
Course Fee
No charge
E-learning content is available on demand
Course Details
Overview
BSI’s interpretation of the guidance and provide manufacturers with practical help on how to apply for a conformity assessment of an orphan device.
Key takeaways and learning objectives
Help on how to apply for a conformity assessment of an orphan device.
You will gain an understanding of the MDCG guidance and will be aware of the process to apply to BSI with a device that qualifies to the criteria.
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What defines a medical device as an Orphan Device (OD)?
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What is expected of manufacturers?
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Considerations and Limitations when documenting a Clinical Evaluation on Orphan Devices.
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The Role of Pre-Clinical Data.
Presenter information
Speaker - Richard Holborow, Head of Clinical Compliance
