In today's interconnected healthcare environment, safeguarding medical devices against cyber threats is paramount. STRATEC stands at the forefront of this critical domain, offering a comprehensive suite of cybersecurity services designed specifically to protect our customer’s medical devices. Our solutions are meticulously aligned with the stringent guidelines laid down in federal regulations such as those issued by the U.S. Food and Drug Administration (FDA). This ensures that our clients not only comply with regulatory requirements but also achieve the highest standards of security and patient safety.
STRATEC’s cybersecurity services encompass a holistic approach, addressing every phase of the medical device lifecycle. From the initial design and development stages to post-market surveillance, our expert team provides robust risk assessments, threat modeling, and continuous monitoring solutions. We implement advanced encryption and operating system hardening, offer dynamic authentication, and provide operating system security update mechanisms. These ensure that devices remain secure against evolving cyber threats in the post-market launch phase and enable our customers to react swiftly to avert cybersecurity threats.
specialized cybersecurity services
STRATEC offers specialized cybersecurity services that include Software Bill of Materials (SBOM), dynamic authentication, and a comprehensive operating system updates process, each tailored to meet FDA guidelines and ensure optimal device security.
Note: STRATEC offers further cybersecurity services on request. For security reasons, not all cyber security measures and services are mentioned on the public website.
SBOM (Software Bill of Materials)
Our SBOM service provides a detailed inventory of all software components within a medical device, ensuring transparency and traceability. This allows for the identification and management of vulnerabilities in third-party and open-source software, facilitating timely and effective remediation efforts. We provide our customers with quarterly reports that list and rate cybersecurity risks. By maintaining an up-to-date SBOM, we help our clients achieve compliance and enhance their cybersecurity posture.
Secure Token Authentication
To fortify access control, STRATEC offers a dynamic authentication solution that excludes the use of static passwords. These layers of security significantly reduce the risk of unauthorized access, ensuring that only verified personnel can interact with medical devices. Our flexible and robust authentication methods adapt to varying security needs, providing an additional safeguard against potential breaches. The dynamic authentication is also a mandatory cybersecurity measure that is requested by the FDA’s regulatory guidelines.
Operating System Security Updates
Keeping medical devices secure requires regular and reliable operating system updates. STRATEC provides a seamless update management service, ensuring that all devices run the latest software with the most recent security patches. In this, STRATEC not only provides the updates but also ensures the testing and verification of our customers’ medical devices. This proactive approach mitigates vulnerabilities and protects against emerging threats, maintaining the integrity and functionality of medical devices in compliance with FDA regulations. Furthermore, STRATEC helps its customers to save valuable time and money by remotely deploying security updates within a short time for an entire fleet.
WHY STRATEC?
By choosing STRATEC, clients can rest assured that their medical devices are protected by cutting-edge cybersecurity measures, fully compliant with FDA guidelines. Our commitment to innovation and excellence in cybersecurity ensures that patient safety and data integrity are always at the forefront of our services.
