Patient safety is a key focus in update of ISO 14155, the industry reference for good practice in clinical trials.
Clinical investigation of medical devices is naturally highly regulated, with numerous national and regional rules and requirements that must be adhered to by manufacturers and investigators, as well as other parties involved in clinical trials.
ISO 14155, Clinical investigation of medical devices for human subjects – Good clinical practice, helps manufacturers comply with the requirements for good clinical practice in the design, conduct and reporting of clinical investigations.
