ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice Published (Edition 3, 2020) Expected to be replaced by ISO/FDIS 14155 within the coming months.

ISO 14155 Clinical investigation of medical devices for human subjects -- Good clinical practice. This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes ...

Will replace ISO 14155:2020 Abstract This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.

This third edition cancels and replaces the second edition (ISO 14155:2011), which has been technically revised. The main changes to the previous edition are as follows:

ISO 14155:redline:2020(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical

Sep 15, 2023 · Become familiar with ISO 14155:2020 so you can conduct a well-executed clinical investigation for your medical device that yields optimal results.

Feb 2, 2021 · The new ISO 14155 standard establishes a need for developing a risk management plan throughout the product life cycle and incorporating it into the clinical investigation plan (CIP) (protocol) before the study begins.

INTERNATIONAL STANDARD ISO 14155:2011(E) © ISO 2011 – All rights reserved 1 Clinical investigation of medical devices for human subjects — Good clinical practice 1 Scope This International Standard addresses good clinical practice …

iso 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.