REGULATORY PUBLICATIONS LIST Over the past few years, a number of Regulatory Authorities across the globe have published materials related to Medical Device Cybersecurity. We've been able to track down links to most of the publications we

Who says back-to-back home runs only occur in baseball or softball?  Because it just happened in Medical Device Cybersecurity.  Health Canada and the Australian Therapeutic & Goods Administration (TGA) both released Cybersecurity guidance in back-to-back months this

Today, Apraciti submitted comments to the Federal eRulemaking Portal (https://www.regulations.gov) on the US Food and Drug Administrations (FDA) draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. We continue to be encouraged by