ISO 13485/88

SIGNIFICANCE OF ISO 13485/88

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.

BENEFITS OF ISO 13485/88

• Improved legal and regulatory or contractual requirements compliance

• Risk identification and management

• Enhanced product safety

• Proactive error detection and prevention

ISO 13485/88 – FOR WHOM

Manufacturers of medical devices and service providers having to fulfill international, European or national legal and regulatory requirements and who want to demonstrate capability to produce and supply safe products and services…