Question

Which of the following is the current international GCP standard for medical devices?

1) ISO 13485
2) ISO 9001
3) ISO 14971
4) ISO 14155

Answer 1

ISO 14155 is the international GCP standard for medical devices, focusing on clinical investigations in human subjects.

Step-by-step explanation:

The current international Good Clinical Practice (GCP) standard for medical devices is ISO 14155. ISO 13485 is related to quality management systems for medical devices, ISO 9001 is a general standard for quality management systems, and ISO 14971 pertains to the application of risk management to medical devices. The current international GCP (Good Clinical Practice) standard for medical devices is ISO 14155. However, ISO 14155 is specifically focused on clinical investigations of medical devices for human subjects, ensuring that these investigations are conducted by ethical principles and that the data collected is credible and reliable.