The EU parliament released a final revision of the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). It includes a number of additions related to software. These additions and clarifications stress that standalone software can be a medical device but not all software used in healthcare is a medical device. It also...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.