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

Latest posts

Are all SBOM tools created equal?
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Are all SBOM tools created equal?

Tools & processes
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Vulnerability management
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Om MahidaOm Mahida
Om Mahida
Medcrypt

April 11, 2024

Are SBOMs moving the needle for improving medical device cybersecurity?
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Are SBOMs moving the needle for improving medical device cybersecurity?

Tools & processes
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Vulnerability management
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Om MahidaOm Mahida
Om Mahida
Medcrypt

March 28, 2024

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

FDA readiness
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Regulatory
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 19, 2024

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

FDA readiness
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Regulatory
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Thought leadership
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Medcrypt

March 18, 2024

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

FDA readiness
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Regulatory
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Thought leadership
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Medcrypt

March 13, 2024

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

FDA readiness
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Regulatory
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

March 11, 2024

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

Thought leadership
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Vulnerability management
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

March 1, 2024

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

Regulatory
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Thought leadership
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Vulnerability management
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Tools & processes
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

February 26, 2024

Meet the Experts: Naomi Schwartz
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Meet the Experts: Naomi Schwartz

Company
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Medcrypt

January 29, 2024

Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations
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Medical Device Cybersecurity - 2023 Learnings and 2024 Expectations

All topics
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 18, 2023

Building Trust in a Connected World: Digital Certificates in Healthcare
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Building Trust in a Connected World: Digital Certificates in Healthcare

Cryptography
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All authorsAll authors
All authors
Medcrypt

November 15, 2023

Medcrypt helps you navigate RTA
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Medcrypt helps you navigate RTA

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

Company
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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

November 3, 2023

Those Crafty Lil’ Buggers
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Those Crafty Lil’ Buggers

Vulnerability management
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Thought leadership
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

November 2, 2023

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

Vulnerability management
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Company
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

September 27, 2023

What is eSTAR?
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What is eSTAR?

Tools & processes
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Cryptography
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FDA readiness
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

September 13, 2023

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

FDA readiness
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

August 29, 2023

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

Cryptography
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Tools & processes
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

July 26, 2023

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

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

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All authorsAll authors
All authors
Medcrypt

April 10, 2023

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

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

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All authorsAll authors
All authors
Medcrypt

April 6, 2023

FDA Cyber Device Guidance — The more you know…
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FDA Cyber Device Guidance — The more you know…

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All authorsAll authors
All authors
Medcrypt

April 5, 2023

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

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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

December 1, 2022

The Need for Scientifically-Sound Cyber Risk Assessment
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The Need for Scientifically-Sound Cyber Risk Assessment

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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

September 14, 2022

I have an SBOM, now what?
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I have an SBOM, now what?

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Mike KijewskiMike Kijewski
Mike Kijewski
Medcrypt

August 2, 2022

FDA’s Cybersecurity Authority in 2023
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FDA’s Cybersecurity Authority in 2023

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

Cryptography
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Naomi SchwartzNaomi Schwartz
Naomi Schwartz
Medcrypt

February 24, 2022

Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity
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Log4Shell Exposes the Mismatched Allocation of Resources in Healthcare Cybersecurity

Vulnerability management
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

January 22, 2022

Omnibus Act Impact on Medical Device Cybersecurity
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Omnibus Act Impact on Medical Device Cybersecurity

Tools & processes
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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

January 11, 2022

The Benefits of Software Transparency
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The Benefits of Software Transparency

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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

December 14, 2021

Medical Device Manufacturer Secure Development Lifecycle
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Medical Device Manufacturer Secure Development Lifecycle

Company
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FDA readiness
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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

October 18, 2021

4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt
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4 Key Constraints Preventing Healthcare from Proper Cybersecurity Medcrypt

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Seth CarmodySeth Carmody
Seth Carmody
Medcrypt

August 2, 2021

What Medical Device Manufacturers Should Learn in 2021
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What Medical Device Manufacturers Should Learn in 2021

Cryptography
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Tools & processes
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All authorsAll authors
All authors
Medcrypt

April 21, 2021

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Research, not marketing

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FDA, RTA and eSTAR - oh my!

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Services

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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.

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