In August 2014, the Australian Therapeutic Goods Authority (TGA) gave a presentation on its approach to software regulation of medical devices. This is a short and very clear high level presentation that explains the TGA’s focus and use of relevant standards such as 62304 as well as its focus on safety and risk management. View...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.