The International Organization for Standardization (ISO) publishes the ISO standard for Good clinical practices (GCP) for the design, conduct, recording, and reporting of clinical studies with medical devices. Conducting your clinical studies according to GCP is important not only to collect good quality data under ethical conditions but also for regulatory compliance in the European Union (EU) and rest of the world. The EU Medical Devices Regulation (MDR) 2017/745 requires clinical investigations to be conducted according to GCP and directly references the ISO14155 standard. The US Food and Drug Administration (FDA) accepts clinical data collected outside the US for market applications under the condition that GCP has been followed. FDA recognizes the ISO 14155 standard for medical device trials. Other regions similarly recognize the GCP standard. Read More