Preface

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. In this book we consider 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 trials 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. Investigators should also be aware that national regulations apply in some countries (not covered in this book) and these must be adhered to.