For italy i confirm you have to register your products in the italian database and class i medical devices manufacturers need to be registered in the netherlands for distribution of medical devices in france a registration process is needed which could be done by authorized representative in case that the manufacturers facility is . Iso 13485 medical devices quality management systems recently updated to iso 134852016 the new version of the internationally recognized standard offers a framework to realize requirements of a medical devices quality management system and seeks to address the entire lifecycle of a medical device. Medical devices make an essential contribution to healthcare in the eu for the benefit of european citizens from sticking plasters to x ray scanners dentures to hip joints and in vitro diagnostic devices that monitor diabetes or identify infections medical devices are crucial in diagnosing preventing monitoring and treating illness and overcoming disabilities. Iso 13485 is the best internationally accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry iso 13485 is the quality management system standard accepted as the basis for ce marking medical devices under european directives and regulations. Directive 98 79 ec of the european parliament and of the council of 27 october 1998 on in vitro diagnostic medical devices directive 2000 70 ec of the european parliament and of the council of 16 november 2000 amending council directive 93 42 eec as regards medical devices incorporating stable derivates of human blood or human plasma
How it works:
1. Register Trial Account.
2. Download The Books as you like ( Personal use )