From the EU MDCG 2019-16 Guidance on Cybersecurity for medical devices, December 2019 , this is the guidance on foreseeable risks. Medical device manufacturers should ensure that a medical device is designed and manufactured in a way that ensures that the risks associated with reasonably foreseeable environmental conditions are removed or minimised. This may include the infield monitoring of the software’s vulnerabilities and the possibility to perform a device update (outside the context of a field safety corrective action) through, for example delivering patches to ensure the continued security of the device. During the risk management process, the manufacturer should foresee or evaluate the potential exploitation of those vulnerabilities that may be a result of reasonably foreseeable misuse. This, however, may depend on the specific situation. For example, using an unsecured memory-stick to enter data into a medical IT system can be considered “reasonably foreseeabl...
Secure Your Code with Threat Modeling As a software developer, security should be a top priority. By proactively identifying and addressing potential vulnerabilities, you can significantly reduce the risk of breaches and data loss. What is Threat Modeling? Threat modeling is a systematic approach to identifying, assessing, and mitigating security threats. It involves looking at your system from a hacker's perspective to uncover weaknesses and devise strategies to protect against attacks. See the OWASP Cheat Sheet Why is Threat Modeling Important? Proactive Security: By anticipating potential threats, you can take steps to prevent them. Risk Mitigation: Identify and address vulnerabilities before they can be exploited. Regulatory Compliance: Adhere to industry standards and regulations. Enhanced Security Posture: Strengthen your overall security posture. How to Get Started with Threat Modeling The Threat Modeling Manifesto provides a valuable framewor...