ISO 13485 Resources
- Buy Standards
- Medical Device Organizations
- Quality and Standards Related Organizations
- Quality Publications
- List of Certified Parties
- Federal Quality Organizations
- Other Links
US Food & Drug Association (www.fda.gov) websites:
- Compliance Program Guidance Manual
- FDA Warning Letters
- Laws Enforced By the Food and Drug Administration
Methodize Inc. – a consulting and training firm specializing in regulatory, clinical and quality services.
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.
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.
National Institute of Standards & Technology – A federal technology agency that works with industry to develop and apply technology, measurements, and standards.
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!