EN ISO 13485 2016 Published

EN ISO 13485:2016 is now available. Similar to EN ISO 13485:2012 it includes tables that shows the relationship between the conformity assessment paths in the MDD, AIMD, and the IVDD. For example, MDD Annex II Section 3.2.c, 9th indent requires a description of the clinical evaluation referred to in Annex X. However, the new QMS standard doesn’t cover this requirement. Table ZB.1 says that 7.3.7, Design and development validation, does not include the details of Annex X.