An overview of cybersecurity regulation/guidance’s evolution in the medical industry
Introduction The last decades have been surrounded by many cybersecurity attacks around the world, many of them in Hospitals or Medical Devices. For example, on September 12th, 2022, the FBI warned that many medical devices with outdated software could be targeted. For this reason, many Regulatory Organizations, such as the Food and Drug Administration (FDA) […]
The transition period for the latest EMC standard for medical devices, IEC 60601-1-2 4.1, will end soon
Introduction In the article below, we will cover the importance of keeping up to date with regulatory standards. A reminder of the final transition date for the EMC collateral norm in the IEC 60601 medical device standard and a brief introduction to the most prominent changes. FDA – Electromagnetic Compatibility (EMC) A medical device is […]