Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Quality management system<br>5 Management responsibility<br>6 Resource management<br>7 Product realization<br>8 Measurement, analysis and improvement<br>Annex A (informative) - Comparison of content between <br> ISO 13485:2003 and ISO 13485:2016<br>Annex B (informative) - Correspondence between <br> ISO 13485:2016 and ISO 9001:2015<br>Bibliography