M00024721
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MEDICAL DEVICE SOFTWARE - PART 2: VALIDATION OF SOFTWARE FOR MEDICAL DEVICE QUALITY SYSTEMS
International Organization for Standardization
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Availability date: 11/05/2021
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> risk-based approach<br>Annex C (informative) - Examples<br>Bibliography
This document applies 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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 210 |