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New
A new revision – ISO 14155: 2020Clinical investigation of medical devices for human subjects
Good clinical practice
The standard ISO 14155 provides essential principles and guidance to any party involved in clinical investigations of medical devices. The third revision...Continue reading
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Issues to be covered
- Background and history of ISO 14155
- Position of ISO 14155 in the regulation of medical devices
- Overview of differences between ISO 14155:2020 and ISO 14155:2011
- Implementation of ISO 14155:2020 in ongoing and future clinical studies
Who should attend
Individuals who are involved in designing and executing clinical studies of medical devices
Benefits to the Participants
Participants in this course will:
- Learn about the similarities and differences between the 2nd and 3rd edition of ISO 14155
- Understand the role of ISO 14155 in the context of medical device regulation
- Get tools to identify gaps in their current clinical study processes
About The Lecturer
