The Essentials of ISO14155:2020

A “must-have” for all clinical research professionals working with medical devices.

ISO1415:2020 is an International Standard on Good Clinical Practice in clinical investigations of medical devices for human subjects. It replaces the previous 2011 standard on this topic.

This easy-to-read guide covers the essentials of ISO14155:2020 on the planning, conduct and close out of the clinical trial as well as the responsibilities of all parties involved in performing, initiating, monitoring, inspecting, and reviewing clinical investigations with medical devices. The requirements described in this book may be applied to pre- and post-market trials in humans with medical devices undertaken in any of the ISO community countries.

By following this summary guide, each party involved in the clinical investigation will have fulfilled most of the important ISO14155:2020 requirements. Resulting in acceptance of the clinical data almost all over the world, which accommodates the conformity assessment of the new medical technology or medical device.

This book has a practical size, that serves as a good reference book at any time. Including a playful visual summary of each chapter of the ISO standard with clear take away messages, reminding you on the essentials of each phase of the clinical investigation.