News

ISO 13485 Revision User Requirements Survey

The International Organization for Standardization (ISO) has set up a committee to determine the need for modification or updating the ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes).

An online questionnaire for the public has been created and the International Organization for Standardization invites medical device firms, government agencies, competent authorities, registrars, industrial organizations and consultants to participate in the survey.
The survey can be found at: www.zoomerang.com/Survey/WEB22CB9ZPRRSP
Answering the questions should take approximately 30 minutes and enables you to comment on ISO 13485 requirements and to take influence on a possible revision of the standard.
The survey will be open for public comments through August 31, 2011 and the committee intends to utilize it to assist in revising ISO 13485:2003.

back