ISO 13485


ISO 13485 Medical Devices

ISO 13485 Medical devices: image of an operating theatre


The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2000 process model approach.

We are formally recognized under the regulatory systems of Europe and Canada and are committed to seeking formal recognition under the USA and Japanese regulatory systems as they evolve and the opportunities arise.







Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device regulations around the world



AGS organization as one of the first organizations which issue this certification with confirmation of medical equipment department of health ministry in nationwide is reliable for its customer in this filed. Our organization with using professional auditors & experts, reached the valuable experiences which is result to effective audit in medical equipment field





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