ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes.
However, it does not apply to in vitro diagnostic medical devices.
This standard was developed by ISO technical committee ISO/TC 194.
The assessment is carried out following defined protocols in this international standard.
Independent assessment bodies carry out independent assessments following auditing principles and practices and protocols in this International Standard.