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Useful links and documents

The main document library on this website is accessed by logging in to the site. The library is an area for all users in the medical device community to share and contribute to the body of knowledge. Below are a few useful links...

 

Association for the Advancement of Medical Instrumentation (AAMI) (USA) - US Standards Organization for medical devices
Association of British Healthcare Industries (ABHI) - British medical device manufacturers trade association
Advamed (formerly HIMA) (USA) - US medical device manufacturers trade association
British In Vitro Diagnostics Association (BIVDA) - British IVD manufacturers trade association
EDMA - European IVD manufacturers trade association
Eucomed - European medical devics manufacturers trade association
The European Commission Site - The European Commission
FDA Center for Devices & Radiological Health (CDRH) (USA) - Regulator of medical devices in the USA
Global Harmonization Task Force for Medical Devices - Collection of documents and information from the GHTF
Medicines Healthcare Products Regulatory Agengy (MHRA) - Regulator of medical devices in the UK
Directive Bulletins (MHRA) – Medical Device Guideline Documents
Medical Devices Canada (Medec) - Canadian medical device manufacturers trade association
NEMA (USA) - US medical device manufacturers trade association
Regulatory Affairs Professionals Society (RAPS) (USA) - Association of regulatory affairs professionals
SAMED - South African Medical Device Industry Association
SANAS Approved Test Laboratories – South African National Accreditation Services
World Health Organisation - perspective on medical devices