This whitepaper explores the importance of cybersecurity in the development of Medical Devices (MD) and In Vitro Diagnostics (IVD). It emphasizes that cybersecurity is not just a static state but a continuous and comprehensive process.
In Part 1, the paper focuses on establishing the right mindset and adapting processes to systematically address cybersecurity concerns. It highlights the need for a holistic approach, moving beyond mere compliance checkboxes and transitioning towards a secure development lifecycle.
Part 2 of the whitepaper delves into cybersecurity threat and risk analysis specific to MD and IVD. It explains how these analyses are applied and integrated into the overall development and verification processes.
The whitepaper concludes by discussing additional lifecycle processes essential for a robust "defense in depth" strategy.