Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016
Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015
Bibliography