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
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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