Medical Device Links

U.S. Food and Drug Administration

European Commission

International Standards

  • AAMI TIR36:2007 – Validation of Software for Regulated Processes
  • AAMI TIR45:2012: Guidance on the use of AGILE practices in the development of medical device software
  • ANSI/AAMI HE75, 2009 Edition – Human Factors Engineering — Design of Medical Devices (Link)
  • ISO/IEC 12207:2008 – Systems and software engineering — Software life cycle processes
  • EN ISO 13485:2012 – Medical devices – Quality management systems – Requirements for regulatory purposes
  • EN ISO 14971:2012 – Medical devices – Application of risk management to medical devices
  • IEC 62304:2006 Medical device software — Software life cycle processes
  • IEC 62366:2007 – Medical devices – Application of usability engineering to medical devices
  • IEC TIR 80002-1:2009 – Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

Health Canada

Therapeutic Goods Administration (TGA), Australia

International Medical Device Regulators Forum (IMDRF)

Conferences