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These
links may prove useful for your company!
Regulatory
Agencies
Australian
Therapeutic Goods Administration (TGA)
Canadian
Therapeutic Products Directorate (TPD)
European
Commission - Medical Device
US
Food and Drug Administration (FDA)
Standards
Organizations and Information
American
National Standards Institute (ANSI)
Canadian
Standards Association (CSA)
European
Committee for Electrotechnical Standardization (CENELEC)
European
Committee for Standardization (CEN)
International
Organization for Standardization (ISO)
International
Electrotechnical Commission (IEC)
International
Safe Transit Association (ISTA)
List
of IVDD Harmonized Standards
List
of MDD Harmonized Standards
Professional
Organizations
Advanced
Medical Technology Association (AdvaMed)
American
Society for Quality (ASQ) Biomedical Division
Association
for the Advancement of Medical Instrumentation (AAMI)
Food
and Drug Law Institute
Medical
Device Manufacturers Association (MDMA)
Regulatory
Affairs Professional Society (RAPS)
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