Navigating FDA 510(k) Submissions – Cybersecurity Controls for Medical Devices
Robert Wilson
To support standards in cyber security for medical devices, the U.S. Food and Drug Administration (FDA) has established rigorous requirements as part of its 510 (k) pre-market submission process. The medical device industry is evolving rapidly, with new innovations transforming patient care and treatment. However, as these devices become increasingly connected and reliant on software, ... Read more