ISO14155:2026 summarized in 12 'golden rules'.              

ISO14155:2026 is an International Standard on Good Clinical Practice in clinical investigations of medical devices for human subjects. It replaces the previous 2020 standard on this topic. In this book we consider the general responsibilities of the clinical trial investigator performing clinical trials on medical devices.

The requirements described in this book may be applied to pre- and post-marketing trials in humans with medical devices undertaken inany 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. The complex requirements are simplified into 12 areas where ISO14155:2026 compliance is most important. An investigator who is able to implement, in each trial, all of the recommendations made in this book will gain the respect of both the regulatory authority inspectors and study sponsors. Investigators who do not comply with ISO14155:2026 will not be invited to undertake trials on new medical devices.

ISO14155:2026 implementation is often tedious and some actions may be perceived as pointless and bureaucratic. However, human subject protection and the collection of reliable data are important in all trials and strict adherence to ISO14155:2026 ensures that the quality processes are in place to meet these goals every time