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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 13485:2016 is the latest version of ISO 13485. This standard is based on the ISO 9001:2015 process model approach.
Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2016 is the international standard recognized for medical device regulations around the world.
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