Several organizations have valuable information to assist Quality System professionals in their job functions.

Standards and Regulatory Organizations

• AAMI - Over 35 years of developing medical device standards. Also a good source for quality system jobs and quality system consultants.
• American National Standards Institute (ANSI) - Source for actionable information on national, regional, international standards and conformity assessment issues.
• British Standards (BSI) - National standards body of the UK.
• Eucomed - European body of national trade and pan-European product associations and internationally active manufacturers of all types of medical technology.
• Food and Drug Administration (FDA) - Regulatory body for medical devices in the US.
• German Institute of Medical Documentation and Information (DIMDI) - Part of the German Federal Ministry of Health whose main task is to provide information in all fields of the life sciences to the interested public.
• Global Harmonization Task Force (GHTF) - International harmonization body in the regulation of medical devices.
• International Organization for Standardization (ISO) - International standard-setting body composed of representatives from various national standards bodies.
  

Trade Associations

• Advamed - Trade association representing manufacturers of medical devices, diagnostic products and medical information systems.
• American Society for Quality (ASQ) - Trade organization for quality improvement.
• Regulatory Affairs Professionals Society (RAPS) - Trade association devoted to the health product regulatory profession.
  

Web Sites Providing Regulatory Information

• Software CPR - A medical device regulatory reference site.
• TUV - Global provider of independent testing and assessment services.
  

Publications

• Medical Device & Diagnostic Industry (MDDI) - Monthly magazine written for original equipment manufacturers of medical devices and in vitro diagnostic products.
• The Gray Sheet - Provides news coverage of the medical device, diagnostics and instrument industry, including regulatory and congressional activities, company developments, new product introductions and investor/finance news.
• The Silver Sheet - Provides coverage of medical device design, compliance and quality control.

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