H34 ISO-14155:2011 - Clinical Investigation of Medical Devices for Human Subjects - Good Practice
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In this course we explore ISO-14155 in detail. ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.
This International Standard specifies general requirements intended to:
- Protect the rights, safety and well-being of human subjects
- Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results
- Define the responsibilities of the sponsor and principal investigator
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.