FDA Draft Infusion Pump Guidance

The Food and Drug Administration (FDA) has posted a draft revised guidance for infusion pumps. This guidance is part of a major FDA initiative to enhance infusion pump safety. It has many references to software and software hazards. It also indicates an assurance/safety case should be provided rather than just a risk analysis. Although this guidance is for infusion pumps it may be indicative of the FDA’s future expectations for other devices and their software as well.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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