Cybersecurity
In the age of the Internet of Things (IoT), cybersecurity is crucial in product design, particularly in medical and industrial technology sectors. It's more than just product protection - it's about preserving sensitive data and system integrity. Countering these threats demands robust device designs for threat resilience, facilitated by a capable and prepared partner.
At IMT, we address cybersecurity head-on by architecting comprehensive security strategies specifically tailored to shield devices from diverse threats. Our approach not only safeguards against targeted attacks, like attempts to install altered software but also defends against broad, non-specific cyber threats such as ransomware and similar malicious software.
Achieving this level of security requires more than just flawless implementation. It necessitates an inherently secure development process, designed with a solid security framework from the onset. Trust in our expertise to safeguard your technology from today's cyber threats.
Engineering for cybersecurity in medical devices
Ensuring the utmost safety and protection for both users and patients is a top priority in medical device development. IMT utilizes the following approaches to reliably achieve this objective in the design process.
Secure software development
Specializing in seamless integration of security protocols for medical device development, our approach anticipates potential vulnerabilities. Using secure coding and threat modeling, we preemptively secure your system, while periodic penetration tests help us identify and eliminate weaknesses. By continuously investing in security awareness and staying updated on emerging cyber threats, we help medical device manufacturers ensure their technology's security, prioritize patient safety, and maintain customer trust in this rapidly evolving digital landscape.
At IMT, we prioritize security in our software development process by incorporating the Secure Software Development Lifecycle (SSDLC). This methodology enables early identification of vulnerabilities, making their mitigation more cost-effective. We commence by integrating cybersecurity into our development procedures, critically evaluating high-risk requirements, and working with clients to devise safer alternatives when necessary. This alignment enhances the resilience of our software.
Security-driven processes
Our processes for development and risk management are based on the current state of the art and take into account not only the standard for software life cycles (IEC 62304) but also the European guidance MDCG 2019-16, the US FDA guidance documents on cyber security or the international standard IEC 81001-5-1.
Device requirements
Not only the processes are essential for cyber security, but we also recognize the critical role of device requirements and accompanying documents in cyber security. Here, too, IMT engineers develop according to the latest industry standards, such as IEC 62443-3-2 and IEC TR 60601-4-5. In doing so, we also take into account, especially for the accompanying documents, the European guidance MDCG 2019-16 as well as the US FDA guidance documents on cyber security.
Consulting
Our team of cyber security and software security experts offers you unparalleled support in implementing these standards within your projects. We also provide analytical and documentation support for your existing devices in addition to new developments. In collaboration with our network of specialized partners, we facilitate authority-mandated penetration tests, thereby securing your devices from potential vulnerabilities.
Contact
Concerned about the cybersecurity of your medical devices? Don't leave your product and patient data vulnerable. Reach out to our IMT engineers today to discuss how we can strengthen your device's security.
Dr. Maxim Mamin
Head of Business Development
Medical Devices
Benno Bieri
Business Development Manager
Medical Devices, System Engineering