Medical Devices-Quality Management System – ISO 13485

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 Market through the world

ISO 13485:2003 is the latest version of ISO 13485, published in July 2003. This standard is based on the ISO 9001:2008 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.