Re: Comparison between ISO13485 and 93/42/EEC Medical Device Directive
There´s no direct comparison between ISO 13485 and the Medical Devices Directive because they´re different things. ISO 13485 is a standard for the implantantion of a quality system for medical devices manufacturers. The MDD is a legislation which adresses essential principles for the safety and performance of medical devices during their lifecycle. One os the requirements of the MDD is a requirement for a quality system or some similar control, so you can use ISO 13485 to fulfill some of these requirements.
If you want a document that relates the essentials principles (which are the Annex I of the MDD and also from the GHTF) to the standards you could use to fulfill them, i strongly recomment "ISO/TR 16142:2006 - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices"
Last edited by Marcelo Antunes; 27th December 2007 at 03:29 PM.