PRIORITY business intelligence

ISO 14155:2011, Clinical investigation of medical devices for human subjects - Good clinical practice, will help to improve the quality of medical devices and encourage manufacturers to guarantee that their products do not compromise patient safety.In 2007, the World Health Organization (WHO) reported that in the United States, more than one million accidents attributable to medical devices occur annually.

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory and other 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.

Source: ISO