A practical guide to medical device encryption for QA and Regulatory professionals. Learn symmetric vs asymmetric encryption, key management, and quantum computing implications.
2026-01-08
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.
Complete guide to creating Software Design Specifications that meet IEC 62304 clause 5.4 and FDA documentation requirements. Includes checklists, examples, and common pitfalls.
2025-11-24
Map IEC 62304 processes to FDA eSTAR requirements. Complete guide to 10 required software documents for medical device submissions with examples.
2025-10-28
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