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.
Balancing Security Controls with Usability in Medical Devices: A Risk-Based Approach Summary When an infusion pump requires three authentication steps in an eme
2025-09-04
Summary This comprehensive guide provides medical device manufacturers with the 12 essential rules for conducting an FDA cybersecurity risk assessment that meet
2025-08-20
Of the Many Documents FDA Requires for Software and Cybersecurity, 24 Must be Attached in Your eSTAR Form Summary Introduction If you’re developing a conn
2025-08-06
How to Systematically Identify Cybersecurity Threats and Meet FDA Requirements Summary STRIDE for medical devices provides a systematic approach to identifying
2025-07-22
Cybersecurity Traceability Matrices FDA Will Expect to See in Your Medical Device Submission Summary In this article, you’ll learn: Introduction A cyberse
2025-07-17
Your Medical Device is Cleared. Your Security Job Just Started. Summary Introduction: The Post-Market Reality Check Your medical device just received FDA cleara
2025-07-09
FDA Updates Cybersecurity Guidance: Key Changes and Clarifications The FDA released an updated version of its cybersecurity guidance document for pre-market sub
2025-06-28
How FDA’s Secure Product Development Framework Enhances Software Lifecycle Processes While Requiring Separate Documentation Packages TL;DR Understanding S
2025-06-25
Failure to build your medical device on a secure architecture costs millions and puts patients at risk Poor security architecture choices early in device design
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
Learn how to develop a robust architecture security view for your medical device, aligning with FDA cybersecurity guidelines, AAMI TIR57, AAMI SW96, and industr
2025-02-14
Learn how to create an effective patch management and security update process to protect your systems from vulnerabilities. This guide covers best practices, to
2025-02-11
Learn how to perform threat modeling for cloud-connected medical devices leveraging FDA’s 2023 cybersecurity guidance and standards such as AAMI TIR57 and AAMI
2025-02-10
FDA cybersecurity requirements apply to any medical device that has software. This surprises many MedTech executives. They assume that only cloud-connected medi
2025-01-31
Over the past decade, the FDA has steadily increased the degree of scrutiny applied to cybersecurity aspects of submissions. From the guidance issued on this to
2024-07-29
Secure software updates are essential for protecting medical devices. As technology continues to advance, the importance of ensuring security through software u
2024-07-18
A startup recently shared with us that they were considering incorporating remote software updates into their medical device. They knew this feature would add a
2024-07-18
In an era where medical devices are increasingly interconnected and software-dependent, cybersecurity has become a critical component of healthcare. The FDA rec
2024-07-18