Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Software validation discussion<br>5 Software validation and critical thinking<br>6 Documentation<br>7 Prerequisite processes<br>Annex A (informative) - Toolbox<br>Annex B (informative) - Risk management and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;risk-based approach<br>Annex C (informative) - Examples<br>Bibliography

Abstract

Pertains to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	CH/62/1