Design Update Capabilities for Medical Devices

With the objective to achieve better results in patient healthcare and lifesaving techniques, regulatory agencies such as the U.S. Food and Drug Administration continue to announce rules and regulations to make medical devices safer and more secure for patients. In a recent 2018 announcement, the FDA released an article, “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health,” that outlines various new FDA actions to improve medical device safety. One of the components of this plan is the call for mandatory built-in capabilities providing safety and security updates to medical devices.