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).

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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