Cybersecurity in Medical Devices- Quality System Considerations and Content of Premarket Submissions

Nov 27, 2023 | White Paper |

Are you interested in implementing cybersecurity controls in your medical devices? You’re in luck! This MEDIcept White Paper will discuss all things cybersecurity with a focus on quality system considerations and the content of premarket submissions.  

Discover insights into the rapidly evolving landscape of cybersecurity in medical devices with the FDA guidance document, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” In a world where medical devices are becoming increasingly interconnected, this document addresses the imperative need for robust cybersecurity controls, especially with the proliferation of wireless and network-connected capabilities.  

Explore the comprehensive approach outlined by the FDA, emphasizing the significance of secure design and mitigation throughout a device's lifecycle. Learn about the groundbreaking Secure Product Development Framework (SPDF) and how the guidance aligns with international recommendations and new cybersecurity requirements introduced by the Consolidated Appropriations Act of 2023. Dive into the future of medical device cybersecurity and stay ahead of the curve in this rapidly evolving field! 

Do you want to learn more about cybersecurity when it comes to your medical devices? MEDIcept has Quality Engineering experts who are here to help. Reach out to us today at 

Click the link below to read the White Paper.