On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software. The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies. This standard is lengthy and technical in terms of its approach to defect...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.