Document Center is acquired by Nimonik

BS EN 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.

The principles set forth in BS EN ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

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.