Amendment 1 of” “IEC 62304 Medical device software — Software Life cycle processes” was issued in 2015. Although the focus of the Amendment was to include a special provision for Legacy software as well as clarifications and changes to Safety Classification, a number of other substantive changes were made.including significant additional requirements for Class A...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.