Cybersecurity for your Medical devices and software

We have extensive expertise in  cybersecurity for medical devices and software. We help manufacturers meet the latest regulatory and industry standards, including IEC 81001-5-1, MDCG 2019-16 r1, and FDA cybersecurity guidance. With the rise of connected healthcare devices and digital health solutions, cybersecurity is essential not only for patient safety but also for maintaining regulatory compliance and market access.

Our team ensures that your devices comply with IEC 81001-5-1 standards, focusing on safety and security in health software systems. We also help you meet the requirements of the MDCG 2019-16 r1 guidance for European market compliance and align with FDA recommendations for cybersecurity management throughout product design, development, and post-market surveillance.

Through a practical cybersecurity approach, documentation writing and review support, and risk monitoring, we help you secure your devices against evolving cyber threats, ensuring both patient safety and regulatory adherence in today’s digital healthcare landscape.

We provide specialized penetration testing services to uncover and address vulnerabilities in your medical devices and software so they cannot be exploited by malicious actors.

Our team conducts thorough testing that simulates real-world attack scenarios, evaluating the effectiveness of your security defenses and identifying potential weaknesses. We collaborate closely with you to ensure our testing aligns with your unique security requirements and regulatory standards. 

Through a streamlined assessment process, we help strengthen your security posture, reduce risk, and enhance the overall resilience of your medical devices and software systems.