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.
principles set forth in ISO 14155:2011 also apply to all
other clinical investigations and should be followed as far
as possible, depending on the nature of the clinical
investigation and the requirements of national regulations.
14155:2011 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 results, define the
responsibilities of the sponsor and principal investigator,
and assist sponsors, investigators, ethics committees,
regulatory authorities and other bodies involved in the
conformity assessment of medical devices.
14155:2011 does not apply to in vitro diagnostic medical