In April 2019, FDA released a draft guidance providing manufacturers and FDA staff with detailed recommendations on assessing the technical performance of quantitative imaging devices and how the documentation from those assessments should be provided in premarket submissions. From a big picture perspective, one should remember the overall goal is to “provide performance specifications for...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 firstname.lastname@example.org for more info.