We safeguard your medical devices every step of the way
Cybersecurity isn't an afterthought but a foundational element ingrained from the inception to the final touches of your product. We understand that safeguarding your medical devices requires proactive measures at every step – from meticulous software development practices to comprehensive threat intelligence and beyond.
Our services
Our tailored services are designed with the unique challenges of medical device manufacturers in mind. We understand the complex landscape you operate in, and our services are here to help you navigate it, covering cybersecurity and regulatory compliance.
Regulatory Compliance
Different markets have different requirements. We support you in identifying and implementing suitable approaches to ensure regulatory compliance across diverse markets.
Software Development
When resources are limited, outsourcing may be the solution. We specialize in developing software using state-of-the-art technology that prioritizes safety and security, allowing you to concentrate on more immediate priorities.
Training and Coaching
Fundamental to success is equipping individuals with the necessary skills. We offer comprehensive training and coaching to facilitate the execution of essential activities and the development of safe and secure products. Our expertise spans from regulatory compliance to intricate aspects of cryptographic engineering.
Our expertise in cybersecure medical technology
Our expertise spans all security-relevant aspects of product development: from risk analysis and secure software architecture to ongoing vulnerability assessments. We work in compliance with international standards such as IEC 62304, IEC 81001-5-1, ISO 14971, and the requirements of the European MDR and US FDA. Whether you're developing implantable medical devices or mobile health applications, we ensure your MedTech solutions are not only innovative but also secure. Because in medical technology, cybersecurity means more than data protection, it means protecting patients.
Security Risk Management
Security starts with a clear understanding of risk. Our security risk management approach identifies potential threats early and evaluates their impact on medical devices and systems. This forms the foundation for targeted protective measures, ensuring maximum patient safety and regulatory compliance.
Threat Modeling
Threat Modeling means thinking like an attacker, before one ever does. By systematically analyzing potential attack scenarios, we identify vulnerabilities as early as the design phase. The result: robust, resilient medical products that embed security from the ground up.
Security Life Cycle / SDLC
Security isn’t a one-time event, it’s a continuous process. We embed cybersecurity into every phase of software and product development, from planning through maintenance. This ensures your MedTech solutions remain protected throughout their entire lifecycle.
SOUP Monitoring & Software Bill of Materials (SBOM)
Both MDR and FDA require submission of your SBOM and continuous monitoring of your SOUP components. Our SBOM monitoring solution keeps you informed about vulnerabilities (CVEs) and their impact on your software stack, enabling timely action and effective risk mitigation.
Cybersecurity Supply Chain Management
Regulatory frameworks like the European MDCG 2019-16 and the FDA cybersecurity premarket submission guidanceset high standards for information security, including your supply-chain. We help ensure your suppliers’ cybersecurity processes meet these requirements.
Through structured due diligence procedures, targeted audits, and in-depth risk analyses, we support you in building a secure and compliant supply chain. This reduces liability risks and strengthens your resilience against cyber threats.
Through structured due diligence procedures, targeted audits, and in-depth risk analyses, we support you in building a secure and compliant supply chain. This reduces liability risks and strengthens your resilience against cyber threats.
How can we support you?
Our expert team is here to tailor solutions specifically to your requirements.
Contact us today to learn more about how we can enhance the security of your medical devices.
Matthias Steck
Senior Expert Consultant Digital Health & Cybersecurity
ISS AG, Integrated Scientific Services
Nordring 4A
3013 Bern
Switzerland
Nordring 4A
3013 Bern
Switzerland
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2026
ISS AG, Integrated Scientific Services