QS Resources: Links
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.