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Navigating FDA Regulations and the Role of ISAOs in Medical Device Cybersecurity
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Navigating FDA Regulations and the Role of ISAOs in Medical Device Cybersecurity

Thought leadership
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Company
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Medcrypt

July 15, 2024

ISACs vs. ISAOs: Understanding the Differences and the Role of MedISAO
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ISACs vs. ISAOs: Understanding the Differences and the Role of MedISAO

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Axel WirthAxel Wirth
Axel Wirth
Medcrypt

July 10, 2024

Understanding the Impact of the Pause in NVD Vulnerability Analysis and Exploring New Solutions
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Understanding the Impact of the Pause in NVD Vulnerability Analysis and Exploring New Solutions

Tools & processes
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Vulnerability management
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MedISAOMedISAO
MedISAO
Medcrypt

May 29, 2024

U.S. Food and Drug Administration (FDA) Extends its Memorandum of Understanding (MOU) with MedISAO
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U.S. Food and Drug Administration (FDA) Extends its Memorandum of Understanding (MOU) with MedISAO

Thought leadership
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Medcrypt

May 20, 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

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)
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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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