ISO 13485:2003 is an international standard based on the ISO 9001:2000 process model. The goal of the ISO 13485:2003 regulation is to assure quality, harmonizing requirements and reduction of the conflicting demands on manufacturers. ISO 13485:2003 provides organizations the credentials to do business abroad and assure quality and consistency for medical device products around the globe. IQS delivers integrated quality software that has been built on a complete integrated quality process model.
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