Presentation by FDA’s Larry Kessler

Presentation by FDA’s Larry Kessler regarding effort to develop new guidelines for risk based pre-market reviews by FDA’s Office of Science and Technology. A key emphasis is on evaluation and justification of residual risk (what we at SoftwareCPR often refer to as establishing a safety case).

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 by Sep 25, 2019 if possible!

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