Welcome to our medical device security blog

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

Latest posts

All topics
Down Arrow
All authors
Down Arrow
Top 5 Things People Get Wrong About SBOM Generation
This is some text inside of a div block.

Top 5 Things People Get Wrong About SBOM Generation

Vulnerability management
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Jobe NaffJobe Naff
Jobe Naff
Medcrypt

October 30, 2024

Cybersecurity in FDA CDRH’s Proposed Guidance List for Fiscal Year 2025
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 28, 2024

Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext
This is some text inside of a div block.

Meeting FDA Cybersecurity Requirements with Medcrypt Guardian & RTI Connext

Company
This is some text inside of a div block.
Cryptography
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

October 22, 2024

One Year Later: The Impact of the PATCH Act and Final Premarket Guidance on Medical Device Cybersecurity
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

October 2, 2024

Leading the Charge in Vulnerability Management with Helm
This is some text inside of a div block.

Leading the Charge in Vulnerability Management with Helm

No items found.
Medcrypt

September 24, 2024

Penetration Testing for Medical Devices: Understanding the Basics and Unique Challenges
This is some text inside of a div block.

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

Tools & processes
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Medcrypt

September 12, 2024

Why Secure DICOM is Poorly Accepted: Understanding the Challenges
This is some text inside of a div block.

Why Secure DICOM is Poorly Accepted: Understanding the Challenges

No items found.
All authorsAll authors
All authors
Medcrypt

September 3, 2024

Top Myths and Deficiencies of Software as a Medical Device (SaMD) Cybersecurity
This is some text inside of a div block.

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

Tools & processes
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Medcrypt

August 27, 2024

Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers
This is some text inside of a div block.

Cybersecurity Risk Exposure of Radiology Practices and Imaging Centers

Thought leadership
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Medcrypt

August 8, 2024

The Current State of DIY Artificial Pancreas Activities
This is some text inside of a div block.

The Current State of DIY Artificial Pancreas Activities

Thought leadership
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 2, 2024

The Critical Importance of Secure Communication in Medical Imaging
This is some text inside of a div block.

The Critical Importance of Secure Communication in Medical Imaging

Thought leadership
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Medcrypt

July 22, 2024

FAQ on Operating Systems (OS) for Medical Devices
This is some text inside of a div block.

FAQ on Operating Systems (OS) for Medical Devices

Vulnerability management
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Medcrypt

July 12, 2024

Medcrypt at the White House: Mike Kijewski's Insights on Securing Medical Devices
This is some text inside of a div block.

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

Thought leadership
This is some text inside of a div block.
Company
This is some text inside of a div block.
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

July 3, 2024

The Supreme Court has dramatically weakened federal regulatory authority. What does that mean for medical device cybersecurity?
This is some text inside of a div block.

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

Thought leadership
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Sara FarnsworthSara Farnsworth
Sara Farnsworth
Medcrypt

July 3, 2024

Software as a Medical Device: Understanding, Regulations, and Security Priorities
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

July 2, 2024

Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors
This is some text inside of a div block.

Case Study: Optimizing Vulnerability Management: Helm Outperforms Competitors

Tools & processes
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

July 1, 2024

What are you missing? Understanding cybersecurity reasons for FDA approval delays
This is some text inside of a div block.

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

Thought leadership
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
FDA readiness
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

June 5, 2024

Decoding SBOM and Vulnerability Management: A Comprehensive Q&A Guide
This is some text inside of a div block.

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

Tools & processes
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Om MahidaOm Mahida
Om Mahida
Medcrypt

May 16, 2024

Decoding FDA Guidance: A Deep Dive into the Premarket Cybersecurity Update
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

May 1, 2024

Case Study: Enhancing Vulnerability Management Efficiency: A Comparative Analysis of Helm and Alternative Tools
This is some text inside of a div block.

Case Study: Enhancing Vulnerability Management Efficiency: A Comparative Analysis of Helm and Alternative Tools

Tools & processes
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

April 24, 2024

Case Study: Elevating Post-Market Vigilance Through Enhanced Vulnerability Detection
This is some text inside of a div block.

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

Tools & processes
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Om MahidaOm Mahida
Om Mahida
Medcrypt

April 17, 2024

Are all SBOM tools created equal?
This is some text inside of a div block.

Are all SBOM tools created equal?

Tools & processes
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Om MahidaOm Mahida
Om Mahida
Medcrypt

April 11, 2024

Are SBOMs moving the needle for improving medical device cybersecurity?
This is some text inside of a div block.

Are SBOMs moving the needle for improving medical device cybersecurity?

Tools & processes
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Om MahidaOm Mahida
Om Mahida
Medcrypt

March 28, 2024

Directors, VPs, and C-Suite Executives’ Approach to FDA Stock Deficiency Letters (Part 4/4)
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 19, 2024

Regulatory Affairs’ Approach to FDA Stock Deficiency Letters (Part 3/4)
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Medcrypt

March 18, 2024

Proposed updates to align FDA Premarket Cybersecurity Guidance with Section 524B of the FD&C Act
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Medcrypt

March 14, 2024

Product Engineers’ Approach to FDA Stock Deficiency Letters (Part 2/4)
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Medcrypt

March 13, 2024

FDA is issuing deficiency letters- why you should care (Part 1/4)
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Regulatory
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 11, 2024

Part 2: HHS Wall of Shame Analysis 2009–2023 — Changing Regulatory Environment
This is some text inside of a div block.

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

Thought leadership
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

March 1, 2024

HHS Wall of Shame Analysis 2009–2023 — Things Ain’t Getting Better (Part 1/2)
This is some text inside of a div block.

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

Regulatory
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Vulnerability management
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

February 26, 2024

Meet the Experts: Naomi Schwartz
This is some text inside of a div block.

Meet the Experts: Naomi Schwartz

Company
This is some text inside of a div block.
Medcrypt

January 29, 2024

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations
This is some text inside of a div block.

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations

All topics
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 18, 2023

Building Trust in a Connected World: Digital Certificates in Healthcare
This is some text inside of a div block.

Building Trust in a Connected World: Digital Certificates in Healthcare

Cryptography
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

November 15, 2023

Medcrypt helps you navigate RTA
This is some text inside of a div block.

Medcrypt helps you navigate RTA

FDA readiness
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

November 9, 2023

Medcrypt Wins University of California San Francisco Digital Health Award for Best in Class in Patient Safety
This is some text inside of a div block.

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

Company
This is some text inside of a div block.
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

November 3, 2023

Those Crafty Lil’ Buggers
This is some text inside of a div block.

Those Crafty Lil’ Buggers

Vulnerability management
This is some text inside of a div block.
Thought leadership
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

November 2, 2023

Happy Final FDA Cybersecurity Premarket Guidance Day to those who celebrate!
This is some text inside of a div block.

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

Vulnerability management
This is some text inside of a div block.
Company
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

September 27, 2023

What is eSTAR?
This is some text inside of a div block.

What is eSTAR?

Tools & processes
This is some text inside of a div block.
Cryptography
This is some text inside of a div block.
FDA readiness
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 13, 2023

Prepare for RTA: What is the FDA Medical Device Review Process?
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 29, 2023

White House’s National Cybersecurity Strategy Implementation Plan (NCSIP)
This is some text inside of a div block.

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

Cryptography
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

July 26, 2023

A Tool to Accelerate Meeting FDA Cybersecurity Expectations: Introducing Helm by MedCrypt
This is some text inside of a div block.

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

FDA readiness
This is some text inside of a div block.
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
This is some text inside of a div block.

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

No items found.
All authorsAll authors
All authors
Medcrypt

April 10, 2023

FDA Cyber Device Guidance — Generate and maintain a software bill of materials (SBOM)
This is some text inside of a div block.

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

No items found.
All authorsAll authors
All authors
Medcrypt

April 7, 2023

FDA Cyber Device Guidance — Monitor and maintain the security of each device for the life of the device
This is some text inside of a div block.

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

No items found.
All authorsAll authors
All authors
Medcrypt

April 6, 2023

FDA Cyber Device Guidance — The more you know…
This is some text inside of a div block.

FDA Cyber Device Guidance — The more you know…

No items found.
All authorsAll authors
All authors
Medcrypt

April 5, 2023

Forbes Technology Council Post: How Does Healthcare Cybersecurity Compare To Other Industries?
This is some text inside of a div block.

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

No items found.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 1, 2022

The Need for Scientifically-Sound Cyber Risk Assessment
This is some text inside of a div block.

The Need for Scientifically-Sound Cyber Risk Assessment

No items found.
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

September 14, 2022

I have an SBOM, now what?
This is some text inside of a div block.

I have an SBOM, now what?

No items found.
Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

August 2, 2022

FDA’s Cybersecurity Authority in 2023
This is some text inside of a div block.

FDA’s Cybersecurity Authority in 2023

No items found.
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
This is some text inside of a div block.

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

Cryptography
This is some text inside of a div block.
Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

February 24, 2022

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity
This is some text inside of a div block.

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity

Vulnerability management
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

January 22, 2022

Omnibus Act Impact on Medical Device Cybersecurity
This is some text inside of a div block.

Omnibus Act Impact on Medical Device Cybersecurity

Tools & processes
This is some text inside of a div block.
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

January 11, 2022

The Benefits of Software Transparency
This is some text inside of a div block.

The Benefits of Software Transparency

No items found.
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

December 14, 2021

Medical Device Manufacturer Secure Development Lifecycle
This is some text inside of a div block.

Medical Device Manufacturer Secure Development Lifecycle

Company
This is some text inside of a div block.
FDA readiness
This is some text inside of a div block.
Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 18, 2021

4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt
This is some text inside of a div block.

4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt

No items found.
Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

August 2, 2021

What Medical Device Manufacturers Should Learn in 2021
This is some text inside of a div block.

What Medical Device Manufacturers Should Learn in 2021

Cryptography
This is some text inside of a div block.
Tools & processes
This is some text inside of a div block.
All authorsAll authors
All authors
Medcrypt

April 21, 2021

Show more

More resources

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.

Latest 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.

Watch now

Want to learn about our services and solutions?

Services

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.

Learn more

Guardian

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

Learn more

Helm

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

Learn more
Copyright © 2024 Medcrypt. All rights reserved.
Privacy policy