As i mentioned some time ago, it was decided to revise ISO 13485.
The below information was distributed to members of ISO TC 210 WG 1:
"Below is a link to a survey that is to be completed by existing users and/or potential users of ISO 13485 2003 and users of other Medical Device Quality Management Systems. The purpose of this questionnaire is to determine the need for modification or updating of the ISO 13485:2003 requirements standard and the ISO/TR 14969:2004 guidance document.
Please complete the following survey by 31 August 2011:
ISO TC210 WG 1 ISO 13485 Revision User Requirements Survey
Please feel free to forward the survey to any medical device firms, government agencies, competent authorities, registrars, industrial organizations and consultants that are appropriate. The survey should take approximately 30 minutes to complete and the deadline is 31 August 2011."