Iso 14155

ISO 14155 is the European standard for medical devices from the International Organization for Standardization (ISO) and corresponds to an adapted guideline of GCP (Good Clinical Practise) for clinical studies with medical devices.

ISO 14155 sets out requirements for the protection of the volunteer and includes guidelines for the development, conduct, recording and reporting of clinical trials that serve as a basis for evaluating the safety or performance of medical devices. In the current version of 2011 there are changes to the previous versions in the definition of safety and product defects

ISO 14155 guarantees the safety and rights of the study participants, controls the study quality, supports all parties involved in a study, regulates risk management and defines the responsibilities of the sponsor, monitor (Clinical Research Associate) and the investigator. It also regulates the contents of the investigator brochure and defines the documents that should be available at the study site and in the sponsor's files.