Welcome to our medical device security blog

Helping advance our industry’s understanding of the challenges and opportunities we face

Latest research

ICYMI: The Legacy Dilemma - Security, Responsibility & Regulation for Connected Medical Devices
October 7, 2025

ICYMI: The Legacy Dilemma - Security, Responsibility & Regulation for Connected Medical Devices

Webinars
Thought leadership
End-of-Life / End-of-Support
MedcryptMedcrypt
Medcrypt
Medcrypt

October 7, 2025

JSP Concept Phase - Laying the Foundation
October 6, 2025

JSP Concept Phase - Laying the Foundation

Secure device communication
Cryptography
Joint Security Plan (JSP)
Stacey MartinezStacey Martinez
Stacey Martinez
Medcrypt

October 6, 2025

Joint Security Plan (JSP) Overview – Cybersecurity Is Everyone’s Job
September 30, 2025

Joint Security Plan (JSP) Overview – Cybersecurity Is Everyone’s Job

All topics
Stacey MartinezStacey Martinez
Stacey Martinez
Medcrypt

September 30, 2025

From Cost Center to Growth Driver: Why Product Cybersecurity is a Business Imperative
September 17, 2025

From Cost Center to Growth Driver: Why Product Cybersecurity is a Business Imperative

Plan & benchmark product security
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 17, 2025

DevSecOps for Medical Devices: Ship Fast. Prove it Easily.
September 15, 2025

DevSecOps for Medical Devices: Ship Fast. Prove it Easily.

Software Bill of Materials (SBOM)
Tools & processes
Vulnerability management
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

September 15, 2025

Preparing for the Post-Quantum Era: What Medical Device Manufacturers Need to Know
September 10, 2025

Preparing for the Post-Quantum Era: What Medical Device Manufacturers Need to Know

All topics
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

September 10, 2025

Legacy Devices and FDA Cybersecurity: What You Need to Know
September 9, 2025

Legacy Devices and FDA Cybersecurity: What You Need to Know

FDA cybersecurity readiness
Regulatory
Thought leadership
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 9, 2025

DOJ Settlement Highlights Growing Cybersecurity Enforcement in Life Sciences
August 28, 2025

DOJ Settlement Highlights Growing Cybersecurity Enforcement in Life Sciences

Regulatory
News & updates
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

August 28, 2025

Introducing the Product Security Intelligence Platform (PSIP): A Smarter Way to Benchmark, Quantify, and Improve Medical Device Cybersecurity
August 18, 2025

Introducing the Product Security Intelligence Platform (PSIP): A Smarter Way to Benchmark, Quantify, and Improve Medical Device Cybersecurity

Plan & benchmark product security
Tools & processes
FDA cybersecurity readiness
All topics
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

August 18, 2025

How Medcrypt's Guardian Helps Medical Device Manufacturers Prepare for the Post-Quantum Future
July 21, 2025

How Medcrypt's Guardian Helps Medical Device Manufacturers Prepare for the Post-Quantum Future

Cryptography
Thought leadership
Post-quantum cryptography (PQC)
News & updates
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

July 21, 2025

Why Preparing for Post-Quantum Cryptography Requires More Than a Firmware Update
July 21, 2025

Why Preparing for Post-Quantum Cryptography Requires More Than a Firmware Update

Cryptography
Thought leadership
Plan & benchmark product security
Post-quantum cryptography (PQC)
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

July 21, 2025

Under Pressure: Why Medical Device Manufacturers Should Shift Focus to Cybersecurity Now
July 17, 2025

Under Pressure: Why Medical Device Manufacturers Should Shift Focus to Cybersecurity Now

Thought leadership
Plan & benchmark product security
Vulnerability management
Software Bill of Materials (SBOM)
Regulatory
Stacey MartinezStacey Martinez
Stacey Martinez
Medcrypt

July 17, 2025

The Intricacies of Linux Patching and Their Impact on Vulnerability Management
July 16, 2025

The Intricacies of Linux Patching and Their Impact on Vulnerability Management

Vulnerability management
Tools & processes
Om MahidaOm Mahida
Om Mahida
Medcrypt

July 16, 2025

How Post-Quantum Readiness Aligns with FDA Expectations for Medical Devices
July 16, 2025

How Post-Quantum Readiness Aligns with FDA Expectations for Medical Devices

Cryptography
All topics
Post-quantum cryptography (PQC)
FDA cybersecurity readiness
Om MahidaOm Mahida
Om Mahida
Medcrypt

July 16, 2025

Linux: The Open-Source Paradox in Medical Device Vulnerability Management – And Why the FDA is Taking Notice
July 9, 2025

Linux: The Open-Source Paradox in Medical Device Vulnerability Management – And Why the FDA is Taking Notice

Vulnerability management
All topics
Tools & processes
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

July 9, 2025

Beyond the Device: Why Securing Medical Manufacturing Infrastructure Is a Patient Safety Imperative
June 27, 2025

Beyond the Device: Why Securing Medical Manufacturing Infrastructure Is a Patient Safety Imperative

Thought leadership
Cryptography
Medcrypt

June 27, 2025

Beyond Compliance: Why Medical Device Security Demands Financial Risk Quantification in Your GRC Program
June 26, 2025

Beyond Compliance: Why Medical Device Security Demands Financial Risk Quantification in Your GRC Program

Plan & benchmark product security
Thought leadership
Medcrypt

June 26, 2025

The C-Suite’s Guide to Incident Response: Why a Proactive Investment Pays Off
June 26, 2025

The C-Suite’s Guide to Incident Response: Why a Proactive Investment Pays Off

Tools & processes
Plan & benchmark product security
Thought leadership
Vulnerability management
Nick AtwellNick Atwell
Nick Atwell
Medcrypt

June 26, 2025

What Is Post-Quantum Cryptography - and Why Should Medical Device Makers Care?
June 24, 2025

What Is Post-Quantum Cryptography - and Why Should Medical Device Makers Care?

Cryptography
Post-quantum cryptography (PQC)
FDA cybersecurity readiness
Regulatory
Stacey MartinezStacey Martinez
Stacey Martinez
Medcrypt

June 24, 2025

Beyond the Tabletop: Introducing Our New Incident Response Readiness Review
June 20, 2025

Beyond the Tabletop: Introducing Our New Incident Response Readiness Review

Tools & processes
FDA cybersecurity readiness
Plan & benchmark product security
Medcrypt

June 20, 2025

Not All Test Labs Are Equal: How to Choose a Trustworthy Testing Vendor
June 12, 2025

Not All Test Labs Are Equal: How to Choose a Trustworthy Testing Vendor

Regulatory
Tools & processes
Thought leadership
Software Bill of Materials (SBOM)
Vulnerability management
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

June 12, 2025

Beyond Encryption: Mastering Key Management and PKI for Medical Device Cybersecurity
June 10, 2025

Beyond Encryption: Mastering Key Management and PKI for Medical Device Cybersecurity

Cryptography
Thought leadership
Medcrypt

June 10, 2025

Cryptographic Realities for Medical Devices vs. Enterprise IT
May 16, 2025

Cryptographic Realities for Medical Devices vs. Enterprise IT

Thought leadership
Tools & processes
Cryptography
Medcrypt

May 16, 2025

The 47-Day Clock: Will Your Medical Device Run Out of Time?
May 16, 2025

The 47-Day Clock: Will Your Medical Device Run Out of Time?

Tools & processes
Vulnerability management
Cryptography
Thought leadership
Medcrypt

May 16, 2025

Navigating the Labyrinth: Vulnerability Management in Medical Devices - It's Okay, You're Not Alone
April 30, 2025

Navigating the Labyrinth: Vulnerability Management in Medical Devices - It's Okay, You're Not Alone

Vulnerability management
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Thought leadership
Medcrypt

April 30, 2025

Navigating Post-Quantum Cryptography in Medical Device Cybersecurity
April 10, 2025

Navigating Post-Quantum Cryptography in Medical Device Cybersecurity

Cryptography
Tools & processes
Post-quantum cryptography (PQC)
Medcrypt

April 10, 2025

Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything Webinar
April 1, 2025

Navigating Medical Device Cybersecurity: Key Takeaways from Our Ask Me Anything Webinar

FDA cybersecurity readiness
Regulatory
Thought leadership
Tools & processes
Vulnerability management
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 1, 2025

Understanding FDA’s Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices
March 28, 2025

Understanding FDA’s Draft Guidance for Predetermined Change Control Plans (PCCPs) for Medical Devices

Regulatory
Thought leadership
FDA cybersecurity readiness
Medcrypt

March 28, 2025

Securing the Past to Protect the Future: Cybersecurity Best Practices for Legacy Medical Devices
March 19, 2025

Securing the Past to Protect the Future: Cybersecurity Best Practices for Legacy Medical Devices

Regulatory
Thought leadership
Vulnerability management
Plan & benchmark product security
Software Bill of Materials (SBOM)
Medcrypt

March 19, 2025

Medical Device Security Strategy for Startups Navigating FDA 510(k) Submissions
March 10, 2025

Medical Device Security Strategy for Startups Navigating FDA 510(k) Submissions

Regulatory
Thought leadership
FDA cybersecurity readiness
Plan & benchmark product security
Stacey MartinezStacey Martinez
Stacey Martinez
Medcrypt

March 10, 2025

Navigate the FDA Draft Guidance on Artificial Intelligence (AI) and Cybersecurity
March 10, 2025

Navigate the FDA Draft Guidance on Artificial Intelligence (AI) and Cybersecurity

Regulatory
FDA cybersecurity readiness
Thought leadership
Software Bill of Materials (SBOM)
Vulnerability management
Medcrypt

March 10, 2025

Got an SBOM — Now What? A Step-by-Step Guide
February 21, 2025

Got an SBOM — Now What? A Step-by-Step Guide

Tools & processes
Thought leadership
Vulnerability management
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

February 21, 2025

End-of-Life (EOL) and End-of-Support (EOS): A Growing Challenge for Medical Device Manufacturers
February 13, 2025

End-of-Life (EOL) and End-of-Support (EOS): A Growing Challenge for Medical Device Manufacturers

Vulnerability management
Software Bill of Materials (SBOM)
Tools & processes
Medcrypt

February 13, 2025

Contec CMS8000 Vulnerability Communication
January 31, 2025

Contec CMS8000 Vulnerability Communication

Vulnerability management
Thought leadership
Plan & benchmark product security
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

January 31, 2025

How to Prepare for FDA’s Likely Cybersecurity Inspection Guide for Medical Devices
January 29, 2025

How to Prepare for FDA’s Likely Cybersecurity Inspection Guide for Medical Devices

FDA cybersecurity readiness
Regulatory
Thought leadership
Tools & processes
Medcrypt

January 29, 2025

Securing Connected Medical Devices: Lessons from Recent Network Intrusions
January 16, 2025

Securing Connected Medical Devices: Lessons from Recent Network Intrusions

Regulatory
Thought leadership
Cryptography
Medcrypt

January 16, 2025

The Overlooked Cyber Threat to Diagnostic Devices: Lessons from Synnovis Cyberattack and Beyond
December 13, 2024

The Overlooked Cyber Threat to Diagnostic Devices: Lessons from Synnovis Cyberattack and Beyond

Tools & processes
Vulnerability management
Software Bill of Materials (SBOM)
Medcrypt

December 13, 2024

Navigating the Evolving Landscape of Medical Device Cybersecurity
December 4, 2024

Navigating the Evolving Landscape of Medical Device Cybersecurity

Thought leadership
Regulatory
Medcrypt

December 4, 2024

Top 5 Things People Get Wrong About SBOM Generation
October 30, 2024

Top 5 Things People Get Wrong About SBOM Generation

Vulnerability management
Tools & processes
Thought leadership
Software Bill of Materials (SBOM)
Jobe NaffJobe Naff
Jobe Naff
Medcrypt

October 30, 2024

Cybersecurity in FDA CDRH’s Proposed Guidance List for Fiscal Year 2025
October 28, 2024

Cybersecurity in FDA CDRH’s Proposed Guidance List for Fiscal Year 2025

FDA cybersecurity readiness
Regulatory
Thought leadership
Vulnerability management
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 28, 2024

Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext
October 22, 2024

Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext

News & updates
Cryptography
Tools & processes
FDA cybersecurity readiness
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

October 22, 2024

One Year Later: The Impact of the PATCH Act and Final Premarket Guidance on Medical Device Cybersecurity
October 2, 2024

One Year Later: The Impact of the PATCH Act and Final Premarket Guidance on Medical Device Cybersecurity

FDA cybersecurity readiness
Regulatory
Thought leadership
Vulnerability management
Software as a Medical Device (SaMD)
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

October 2, 2024

Leading the Charge in Vulnerability Management with Helm
September 24, 2024

Leading the Charge in Vulnerability Management with Helm

Vulnerability management
FDA cybersecurity readiness
News & updates
Software Bill of Materials (SBOM)
Medcrypt

September 24, 2024

Penetration Testing for Medical Devices: Understanding the Basics and Unique Challenges
September 12, 2024

Penetration Testing for Medical Devices: Understanding the Basics and Unique Challenges

Tools & processes
Thought leadership
Plan & benchmark product security
Medcrypt

September 12, 2024

Why Secure DICOM is Poorly Accepted: Understanding the Challenges
September 3, 2024

Why Secure DICOM is Poorly Accepted: Understanding the Challenges

Cryptography
Thought leadership
Regulatory
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

September 3, 2024

Top Myths and Deficiencies of Software as a Medical Device (SaMD) Cybersecurity
August 27, 2024

Top Myths and Deficiencies of Software as a Medical Device (SaMD) Cybersecurity

Tools & processes
Thought leadership
Vulnerability management
Software as a Medical Device (SaMD)
FDA cybersecurity readiness
Medcrypt

August 27, 2024

Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers
August 8, 2024

Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers

Thought leadership
Tools & processes
Regulatory
Vulnerability management
Medcrypt

August 8, 2024

The Current State of DIY Artificial Pancreas Activities
August 2, 2024

The Current State of DIY Artificial Pancreas Activities

Thought leadership
Vulnerability management
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 2, 2024

The Critical Importance of Secure Communication in Medical Imaging
July 22, 2024

The Critical Importance of Secure Communication in Medical Imaging

Thought leadership
Regulatory
Cryptography
Medcrypt

July 22, 2024

FAQ on Operating Systems (OS) for Medical Devices
July 12, 2024

FAQ on Operating Systems (OS) for Medical Devices

Vulnerability management
Thought leadership
Tools & processes
Software Bill of Materials (SBOM)
Regulatory
Medcrypt

July 12, 2024

The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?
July 3, 2024

The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?

Thought leadership
Regulatory
Sara FarnsworthSara Farnsworth
Sara Farnsworth
Medcrypt

July 3, 2024

Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices
July 3, 2024

Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices

Thought leadership
News & updates
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

July 3, 2024

Software as a Medical Device: Understanding, Regulations, and Security Priorities
July 2, 2024

Software as a Medical Device: Understanding, Regulations, and Security Priorities

FDA cybersecurity readiness
Tools & processes
Vulnerability management
Software as a Medical Device (SaMD)
Thought leadership
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

July 2, 2024

Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors
July 1, 2024

Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors

Tools & processes
Vulnerability management
Thought leadership
Software Bill of Materials (SBOM)
Case studies
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

July 1, 2024

What are you missing? Understanding cybersecurity reasons for FDA approval delays
June 5, 2024

What are you missing? Understanding cybersecurity reasons for FDA approval delays

Thought leadership
Regulatory
FDA cybersecurity readiness
Vulnerability management
Software Bill of Materials (SBOM)
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

June 5, 2024

Decoding SBOM and Vulnerability Management: A Comprehensive Q&A Guide
May 16, 2024

Decoding SBOM and Vulnerability Management: A Comprehensive Q&A Guide

Tools & processes
Thought leadership
Software Bill of Materials (SBOM)
Vulnerability management
Om MahidaOm Mahida
Om Mahida
Medcrypt

May 16, 2024

Decoding FDA Guidance: A Deep Dive into the Premarket Cybersecurity Update
May 1, 2024

Decoding FDA Guidance: A Deep Dive into the Premarket Cybersecurity Update

FDA cybersecurity readiness
Regulatory
Thought leadership
Software Bill of Materials (SBOM)
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

May 1, 2024

Case Study: Precision in Practice- How Helm Redefines SBOM Vulnerability Management
April 24, 2024

Case Study: Precision in Practice- How Helm Redefines SBOM Vulnerability Management

Tools & processes
Case studies
FDA cybersecurity readiness
Plan & benchmark product security
Software Bill of Materials (SBOM)
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 24, 2024

Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection
April 17, 2024

Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection

Tools & processes
Thought leadership
Vulnerability management
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Om MahidaOm Mahida
Om Mahida
Medcrypt

April 17, 2024

Are all SBOM tools created equal?
April 11, 2024

Are all SBOM tools created equal?

Tools & processes
Vulnerability management
Software Bill of Materials (SBOM)
Thought leadership
Om MahidaOm Mahida
Om Mahida
Medcrypt

April 11, 2024

Are SBOMs moving the needle for improving medical device cybersecurity?
March 28, 2024

Are SBOMs moving the needle for improving medical device cybersecurity?

Tools & processes
Vulnerability management
Om MahidaOm Mahida
Om Mahida
Medcrypt

March 28, 2024

Directors, VPs, and C-Suite Executives’ Approach to FDA Stock Deficiency Letters (Part 4/4)
March 19, 2024

Directors, VPs, and C-Suite Executives’ Approach to FDA Stock Deficiency Letters (Part 4/4)

FDA cybersecurity readiness
Regulatory
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 19, 2024

Regulatory Affairs’ Approach to FDA Stock Deficiency Letters (Part 3/4)
March 18, 2024

Regulatory Affairs’ Approach to FDA Stock Deficiency Letters (Part 3/4)

FDA cybersecurity readiness
Regulatory
Thought leadership
Medcrypt

March 18, 2024

Proposed updates to align FDA Premarket Cybersecurity Guidance with Section 524B of the FD&C Act
March 14, 2024

Proposed updates to align FDA Premarket Cybersecurity Guidance with Section 524B of the FD&C Act

FDA cybersecurity readiness
Thought leadership
Regulatory
Medcrypt

March 14, 2024

Product Engineers’ Approach to FDA Stock Deficiency Letters (Part 2/4)
March 13, 2024

Product Engineers’ Approach to FDA Stock Deficiency Letters (Part 2/4)

FDA cybersecurity readiness
Regulatory
Thought leadership
Medcrypt

March 13, 2024

FDA is issuing deficiency letters- why you should care (Part 1/4)
March 11, 2024

FDA is issuing deficiency letters- why you should care (Part 1/4)

FDA cybersecurity readiness
Regulatory
Thought leadership
Tools & processes
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 11, 2024

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment
March 1, 2024

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment

Thought leadership
Vulnerability management
Software Bill of Materials (SBOM)
Regulatory
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

March 1, 2024

HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)
February 26, 2024

HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)

Regulatory
Thought leadership
Vulnerability management
Tools & processes
Software Bill of Materials (SBOM)
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

February 26, 2024

Meet the Experts: Naomi Schwartz
January 29, 2024

Meet the Experts: Naomi Schwartz

News & updates
Regulatory
FDA cybersecurity readiness
Medcrypt

January 29, 2024

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations
December 18, 2023

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations

All topics
Thought leadership
Regulatory
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 18, 2023

Building Trust in a Connected World: Digital Certificates in Healthcare
November 15, 2023

Building Trust in a Connected World: Digital Certificates in Healthcare

Cryptography
Thought leadership
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

November 15, 2023

Medcrypt helps you navigate RTA
November 9, 2023

Medcrypt helps you navigate RTA

FDA cybersecurity readiness
Thought leadership
Plan & benchmark product security
Tools & processes
Vulnerability management
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

November 9, 2023

Medcrypt Wins University of California San Francisco Digital Health Award for Best in Class in Patient Safety
November 3, 2023

Medcrypt Wins University of California San Francisco Digital Health Award for Best in Class in Patient Safety

News & updates
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

November 3, 2023

Hardware Attacks: Malicious Cables & Supply Chain
November 2, 2023

Hardware Attacks: Malicious Cables & Supply Chain

Vulnerability management
Thought leadership
Software Bill of Materials (SBOM)
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

November 2, 2023

Happy Final FDA Cybersecurity Premarket Guidance Day to those who celebrate!
September 27, 2023

Happy Final FDA Cybersecurity Premarket Guidance Day to those who celebrate!

Vulnerability management
News & updates
FDA cybersecurity readiness
Software Bill of Materials (SBOM)
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

September 27, 2023

What is eSTAR?
September 13, 2023

What is eSTAR?

Tools & processes
FDA cybersecurity readiness
Vulnerability management
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 13, 2023

Prepare for RTA: What is the FDA Medical Device Review Process?
August 29, 2023

Prepare for RTA: What is the FDA Medical Device Review Process?

FDA cybersecurity readiness
Regulatory
Software Bill of Materials (SBOM)
Vulnerability management
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 29, 2023

White House’s National Cybersecurity Strategy Implementation Plan (NCSIP)
July 26, 2023

White House’s National Cybersecurity Strategy Implementation Plan (NCSIP)

Cryptography
Tools & processes
Regulatory
Software Bill of Materials (SBOM)
Vulnerability management
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

July 26, 2023

A Tool to Accelerate Meeting FDA Cybersecurity Expectations: Introducing Helm by MedCrypt
June 21, 2023

A Tool to Accelerate Meeting FDA Cybersecurity Expectations: Introducing Helm by MedCrypt

FDA cybersecurity readiness
Vulnerability management
Software Bill of Materials (SBOM)
Tools & processes
Medcrypt

June 21, 2023

FDA Cyber Device Guidance — Generate and maintain requisite documentation proving you’ve done so as part of your FDA regulatory submission
April 10, 2023

FDA Cyber Device Guidance — Generate and maintain requisite documentation proving you’ve done so as part of your FDA regulatory submission

FDA cybersecurity readiness
Vulnerability management
Thought leadership
Regulatory
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 10, 2023

FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)
April 7, 2023

FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)

Regulatory
FDA cybersecurity readiness
Plan & benchmark product security
Thought leadership
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 7, 2023

FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device
April 6, 2023

FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device

FDA cybersecurity readiness
Regulatory
Vulnerability management
Software Bill of Materials (SBOM)
Thought leadership
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 6, 2023

FDA Cyber Device Guidance — The more you know…
April 5, 2023

FDA Cyber Device Guidance — The more you know…

Regulatory
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Thought leadership
Vulnerability management
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 5, 2023

Forbes Technology Council Post: How Does Healthcare Cybersecurity Compare To Other Industries?
December 1, 2022

Forbes Technology Council Post: How Does Healthcare Cybersecurity Compare To Other Industries?

Thought leadership
News & updates
Software Bill of Materials (SBOM)
Vulnerability management
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 1, 2022

The Need for Scientifically-Sound Cyber Risk Assessment
September 14, 2022

The Need for Scientifically-Sound Cyber Risk Assessment

Plan & benchmark product security
Thought leadership
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

September 14, 2022

I have an SBOM, now what?
August 2, 2022

I have an SBOM, now what?

Software Bill of Materials (SBOM)
Tools & processes
Vulnerability management
FDA cybersecurity readiness
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

August 2, 2022

FDA’s Cybersecurity Authority in 2023
March 29, 2022

FDA’s Cybersecurity Authority in 2023

FDA cybersecurity readiness
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

March 29, 2022

Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way
February 24, 2022

Healthcare Is A Cyber Criminal’s Dream, But It Doesn’t Have To Be This Way

Cryptography
Regulatory
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

February 24, 2022

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity
January 22, 2022

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity

Vulnerability management
Software Bill of Materials (SBOM)
FDA cybersecurity readiness
Plan & benchmark product security
Thought leadership
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

January 22, 2022

Omnibus Act Impact on Medical Device Cybersecurity
January 11, 2022

Omnibus Act Impact on Medical Device Cybersecurity

Tools & processes
Regulatory
Thought leadership
Software Bill of Materials (SBOM)
Vulnerability management
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

January 11, 2022

The Benefits of Software Transparency
December 14, 2021

The Benefits of Software Transparency

Software Bill of Materials (SBOM)
Thought leadership
Vulnerability management
FDA cybersecurity readiness
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

December 14, 2021

Medical Device Manufacturer Secure Development Lifecycle
October 18, 2021

Medical Device Manufacturer Secure Development Lifecycle

News & updates
FDA cybersecurity readiness
Tools & processes
Software Bill of Materials (SBOM)
Vulnerability management
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 18, 2021

4 Key Constraints Preventing Healthcare from Proper Cybersecurity
August 2, 2021

4 Key Constraints Preventing Healthcare from Proper Cybersecurity

Thought leadership
Regulatory
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

August 2, 2021

What Medical Device Manufacturers Should Learn in 2021
April 21, 2021

What Medical Device Manufacturers Should Learn in 2021

Cryptography
Tools & processes
FDA cybersecurity readiness
Vulnerability management
Software Bill of Materials (SBOM)
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

April 21, 2021

2024 H-ISAC Fall Summit: Cybersecurity in Healthcare with Medcrypt

2024 H-ISAC Fall Summit: Cybersecurity in Healthcare with Medcrypt

Thought leadership
News & updates
Medcrypt cybersecurity teamMedcrypt cybersecurity team
Medcrypt cybersecurity team
Medcrypt

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Research, not marketing

We are dedicated to helping advance our industry’s understanding of the challenges and opportunities we face through research. Check out our whitepapers.

FDA, RTA and eSTAR - oh my!

Watch our latest webinar that discusses regulatory updates and the impact for medical device development and post-market management.

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No matter where you are in the regulatory submission process, we have a variety of services that can meet your needs when and where you need us.

Guardian

The Guardian platform is a secure and scalable cryptographic solution that simplifies security processes and incident response.

Helm

Gain visibility across your software supply chain to detect, prioritize, and remediate cybersecurity risk.