ISO 13485:2003 is an international standard adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement.


E & E Medicals will you  implement processes and procedures that comply with the requirements listed in ISO 13485:2003, you can be audited by a third party organization called Registrar such as TUV who will certify your organization to this standard. It will also meet most of the FDA requirements to have a Quality System in compliance with the QSRs set forth by 21CFR820.


To learn more about ISO� 13485 registration contact us today