Medical device cybersecurity guidance, built for action.
Explore practical whitepapers that turn regulatory expectations and lifecycle cybersecurity responsibilities into clear next steps for medical device teams.
The JSP Quick Reference Guide helps medical device teams understand their role in building and maintaining a secure product. Using the cybersecurity house analogy, it simplifies complex regulatory requirements into four phases — Concept, Design & Development, Verification & Validation, and Maintenance — so everyone, from product managers to executives, can see where they fit and what’s expected of them.
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.
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.
Discover essential tools and processes for medical device cybersecurity compliance. This paper proposes a hypothetical vendor's mature program, analyzing how it meets FDA Premarket and Postmarket Guidance to ensure "secure by design" devices.
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