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The Ultimate QA/RA Cheat Sheet

By Thomas Maeder
2 Comments
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It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.

Trade Associations

  • AMDM (Association of Medical Diagnostics manufacturers) – AMDM is a nonprofit trade association that serves as an educational resource for regulatory submissions and other compliance information related to the in vitro diagnostic industry
  • MDMA (Medical Device Manufacturers Association) – MDMA is a national trade association based in Washington, D.C. providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies
  • AdvaMed – AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve  healthier lives and healthier economies around the world

Academia

Feel free to send us your suggestions to make this a living, growing list.

Northeastern graduate students Tejasri Parchuri, Aayushi Kasilwai, Kruti Damani and Yi Zhang contributed to an updated version of this guide.

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About The Author

Tom Maeder, MedTech Intelligence

Comments

  1. David A. Manalan

    Great job. I gave it a plus from me on LinkedIn. One nit- The Global Harmonization Task Force (GHTF) website is no longer operational. For information about medical device harmonization, please go to:
    http://www.imdrf.org
    Great find- Quality Systems Manual – A comprehensive, easily readable small entity compliance guide to the medical device quality systems. Very difficult to find it by searching.

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