ISO 13485 Resources
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Buy Standards from Techstreet.com
ISO 13485: 2003 (July/03) Buy Now
Medical devices - Quality management systems - Requirements for regulatory purposes.
Medical Device Industry Organizations
US Food & Drug Association (www.fda.gov) websites:
Medical Device Link
Global Harmonization Task Force
Health Canada
The Medical Devices Bureau of Health Canada
The Medicines and Healthcare products Regulatory Agency (MHRA)
Australian Government Department of Health & Ageing
Consultants
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
Registrars
BSI
See our Registrars pag
Select a Registrar
List of Certified Companies
Who's Registered
QSU Online ISO 9000 Registered Company Directory
Quality Digest ISO 9000 Directory
U.S. Government 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.