EN ISO 13485, as the EU harmonized standard for medical device quality management systems, is an essential tool allowing medical device manufacturers to prove evidence of compliance to the European legislation.
To restore confidence and bring back the presumption of compliance indicated by the harmonized status of the standard, it was essential to revise the Annexes ZA, ZB and ZC and add further details on the link between standards and the Medical Device Directives.
In accordance to new version of EN ISO 13485:2012 we would like to provide you a brief information about it.
Here you can download document: EN ISO 13485:2012 Published.