No single entity is going to “fix” medical device cybersecurity. We are dedicated to advancing our collective understanding of the challenges and opportunities we face through research.
The documents below are free to download, and we’re not going to do that thing where we ask for your email address in order to download them. We love feedback — so tell us if you love it, hate it or want to enhance it together.
Software bills of material (SBOM) capture software used in products. SBOMs are prerequisites to proactive product security, as well as vulnerability and risk management programs. However, extracting the full potential value of SBOMs at scale will take sustained effort, requiring tooling to overcome inherent complexities.
The sobering reality is that all the promise held in technology advancing healthcare is foundationally reliant on security. Unfortunately, not only does the healthcare supply chain inherit what makes information security hard, healthcare additionally inherits economic constraints that allow security debt to pass to consumers. Watch the webinar where Seth explores the six constraints: https://youtu.be/1pYlbqkM9Ew
With medical devices being increasingly network-connected, we leveraged our collective expertise in medical device security and clinical risk management, to provide a holistic analysis of vulnerabilities in the medical device space through the assessment of clinical case studies using quantitative analytics, and a discussion of incident prevention recommendations.
There is no silver bullet. Complying with FDA cybersecurity regulations requires a variety of processes and technologies. A hypothetical device vendor’s approach to securing their product is analyzed, and leading tools are identified.
In this paper we highlight the specific cybersecurity requirements that can be satisfied using various features of MedCrypt.
Medical device cybersecurity requirements from global regulators will continue to evolve as the industry and ecosystem matures. The industry must be cautious against over reliance on “security frameworks” and must rapidly iterate to keep up with emerging technology best practices.
Watch our latest webinar that discusses regulatory updates and the impact for medical device development and post-market management.
No matter where you are in the regulatory submission process, we have a variety of services that can meet your needs when and where you need us.
The Guardian platform is a secure and scalable cryptographic solution that simplifies security processes and incident response.
Gain visibility across your software supply chain to detect, prioritize, and remediate cybersecurity risk.