Useful information

These are sites and organizations that I find useful for software organizations who are considering moving products into medical device markets. I actually maintain this page for me since I find that when I need **that** reference I can never find the darn thing. If it helps you, too, then great!

Updated August 2019

IMDRF

  • Software as a Medical Device from the IMDRF
    • The FDA is looking more (and leading this subgroup (aka Consultation) in the IMDRF) to the IMDRF for guidance in this area. Scroll down after the link to see who is involved and what documents were produced. This is really good reading since the FDA is leading the charge here.

FDA References

FDA & Cybersecurity

The FDA has recently focused on cybersecurity. There is a complete section on this with good information.

IEC, ISO, and other standards bodies

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