Insights

Field notes from the MedTech security trenches.

Deep dives on FDA expectations, threat modeling, penetration testing, SDLC, and the standards your team is being asked to meet.

Primer· Mar 17, 2024

Ephemeral Ports in Medical Device Cybersecurity (What to Know)

Ephemeral ports affect firewall rules, logging, and threat models for connected medical devices. Learn ranges, risks, and practical controls.

#Primer

Read article

Primer· Mar 10, 2024

LoRaWan Vulnerabilities on Medical Device Cybersecurity

Discover the potential risks and implications of LoRaWan vulnerabilities on the cybersecurity of medical devices.

#Primer

Read article

Primer· Mar 10, 2024

RFID and Medical Device Cybersecurity

Discover the crucial role of RFID technology in safeguarding medical devices from cyber threats.

#Primer

Read article

Primer· Mar 3, 2024

CIA Triad vs. NSA Controls in Medical Device Cybersecurity

Explore how the CIA Triad and NSA cybersecurity controls strengthen medical device security and support FDA compliance from design to postmarket.

#Primer

Read article

Cryptography· Mar 3, 2024

Symmetric Key Encryption for Medical Devices: A Practical Guide to AES and Key Management

Learn how symmetric encryption works in medical devices, where AES fits, and what strong key management looks like for FDA-ready cybersecurity documentation.

#Cryptography

Read article

Primer· Mar 3, 2024

Replay Attacks on BLE & MICS Medical Devices

Replay attacks are a core threat to BLE and MICS-enabled medical devices. How MedTech manufacturers detect and prevent replay in wireless protocols.

#Primer

Read article

FDA· Mar 3, 2024

VxWorks Vulnerabilities in Medical Devices: Triage, SBOM & §524B Evidence

How MedTech teams should identify, triage, and document VxWorks RTOS vulnerabilities (URGENT/11 and beyond) for FDA Section 524B premarket and postmarket submissions.

#FDA#SBOM

Read article

Primer· Mar 2, 2024

What Is the Electronic Frontier Foundation (EFF)? Why It Matters for Medical Device Cybersecurity

Discover the Electronic Frontier Foundation (EFF) and its role in protecting digital rights and privacy.

#Primer

Read article

Testing· Mar 2, 2024

The Importance of Medical Device Vulnerability Testing

Learn why medical device vulnerability testing is crucial for patient safety and data security.

#Testing

Read article

FDA· Mar 2, 2024

Self‑Aware AI in Medical Devices: Risks, Requirements, and FDA Implications

Delve into the fascinating world of self-aware AI as we explore the concept, implications, and potential of artificial intelligence that possesses self-awareness.

#FDA#Risk#AI

Read article

Primer· Mar 1, 2024

Microkernels for Medical Devices: Security Benefits and Tradeoffs

Microkernels can improve isolation and reduce trusted code in medical devices. Learn real tradeoffs, design patterns, and FDA-friendly evidence ideas.

#Primer

Read article

Cryptography· Mar 1, 2024

3 Ways Hackers Break Encryption in Medical Devices

Learn how brute force, side-channel, and cryptanalysis attacks compromise encryption in medical devices - and how to secure your product before FDA submission.

#Cryptography

Read article

Ready when you are

Get FDA cleared without the cybersecurity headaches.

30-minute strategy session. No cost, no commitment - just answers from people who've shipped 250+ submissions.