ISO 13485 Resources

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Medical Device Industry Organizations

US Food & Drug Association ( websites:

Medical Device Link

Health Canada

The Medical Devices Bureau of Health Canada

The Medicines and Healthcare products Regulatory Agency (MHRA)

Australian Government Department of Health & Ageing


Methodize Inc. – a consulting and training firm specializing in regulatory, clinical and quality services.

Quality Related Organizations

ISO – International Standards for Organization

ASQ – The world’s leading membership organization devoted to quality

ANSI-ASQ National Accreditation Board (ANAB) – The US accreditation body for QMS certification. They offer a directory of Registrars and other resources.

NQI National Quality Institute

RABQSA – Designs, develops, and delivers personnel and training certification for various standards (ISO 9001, etc.)

Society for Quality Assurance – Research and Regulatory Information

American National Standards Institute – American National Standards Institute (ANSI) web site offers up-too-date resources on national and international standards activities. International Quality Organizations by Country: Please contact us to add your info.

Quality Publications

Quality Digest

Quality Magazine


See our Registrars page

List of Certified Companies

Who’s Registered

Federal Quality Organizations

MEP (Manufacturing Extension Partnerships) – A nationwide network of resources transforming manufacturers to compete globally.

National Institute of Standards & Technology – A federal technology agency that works with industry to develop and apply technology, measurements, and standards.

Other Links

ISO 9001 Compliance & ISO 9001:2008 – ISO 9001 Compliance: Your ISO 9001 Resource for information, books, article, consulting, and more. Including the new ISO 9001 2008 Standard. Total Quality Management at its best!

ISO 9001 All in One Package