Map IEC 62304 processes to FDA eSTAR requirements. Complete guide to 10 required software documents for medical device submissions with examples.
2025-10-28
MedTech cybersecurity guidance, organized for action.
Quickly find the playbooks, templates, and analysis that map to your stage—whether you are preparing a submission, maturing threat models, or operating in market.
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Browse the latest analysis on cybersecurity requirements across the device lifecycle.
Shows how medical device teams can balance cybersecurity controls with clinical usability through risk-based design, collaboration, and FDA-aligned documentation.
2025-09-04
Breaks down twelve rules for creating FDA-ready cybersecurity risk assessments, covering threat discovery, scoring, mitigation, and documentation evidence.
2025-08-20
Catalogs the software and cybersecurity documents FDA expects in eSTAR submissions and offers guidance on organizing evidence for reviewers.
2025-08-06
Shows how to use the STRIDE framework to categorize threats, map mitigations, and meet FDA cybersecurity expectations.
2025-07-22
Details how to build cybersecurity traceability matrices that connect threats, controls, and verification evidence for modern FDA submissions.
2025-07-17
Covers the monitoring, vulnerability response, and legacy planning manufacturers need to keep medical devices cybersecure after FDA clearance.
2025-07-09
Highlights what changed in the FDA's June 27, 2025 cybersecurity guidance update and what it means for pre-market submissions.
2025-06-28
Clarifies how FDA's Secure Product Development Framework complements IEC 62304 and what dual documentation packages reviewers expect.
2025-06-25
Explains why secure architecture decisions early in development prevent costly rework and position medical devices for smoother FDA cybersecurity reviews.
2025-06-18
Explore the innovative application of the Common Vulnerability Scoring System (CVSS) in medical device risk assessment.
2025-04-26
Discover essential strategies for safeguarding your digital assets with our comprehensive guide on implementing cybersecurity controls.
2025-02-20
Discover the essential steps and best practices for conducting effective penetration testing.
2025-02-19
Discover the essential steps to integrate security into every phase of your software development lifecycle.
2025-02-19
Unlock the secrets of creating effective data flow diagrams tailored for medical devices.
2025-02-18
Discover the essential steps and best practices for conducting a thorough security code review.
2025-02-18
Walks through building a medical device security architecture view that satisfies FDA expectations and AAMI SW96 guidance.
2025-02-14
Provides a step-by-step playbook for building an FDA-aligned patch and security update program for connected devices.
2025-02-11
Guides teams through threat modeling a cloud-connected device using FDA's 2023 cybersecurity guidance alongside AAMI TIR57 and SW96.
2025-02-10
Summarizes FDA cybersecurity obligations for software-based medical devices across development, submission, and post-market phases.
2025-01-31
Outlines five cybersecurity gaps that now trigger FDA refusal-to-accept decisions for 510(k) submissions and how to close them.
2024-07-29
Explains the capabilities, controls, and process steps needed to ship secure medical device software updates.
2024-07-18
Makes the case that remote update capability is now essential under FDA cybersecurity rules and explains how to implement it safely.
2024-07-18
Breaks down the cybersecurity evidence FDA expects in submissions for software-enabled medical devices.
2024-07-18