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Cybersecurity in Medical Device Development: A Total Product Lifecycle Approach Pt 2
July 3, 2025 John O'Gorman

Ensuring robust cybersecurity across the entire lifecycle of a medical device, while aligning with evolving regulatory expectations...

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Cybersecurity in Medical Device Development: A Total Product Lifecycle Approach Pt 1
June 25, 2025 John O'Gorman

In medical device development, focus is mainly on innovation, functionality, and time-to-market, while cybersecurity can sometimes...

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Why Medtech Companies Need a Data Strategy—And How to Build One
March 11, 2025 Lieneke Hodnett

This article is based on our recent webinar, "Building Effective Data Strategies that Unlock the True Potential of Smart Connected...

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Top Digital Health Trends to Watch in 2025
January 7, 2025 Lieneke Hodnett

As we look ahead to 2025, we can see how the healthcare industry will continue to be shaped by advancements in AI; revolutionizing...

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Section 524B Amendment of the FD&C Act, ‘Ensuring Cybersecurity of Devices’ – Guidance and Requirements for Medtech
October 18, 2023 John O'Gorman

As technology becomes more integrated into healthcare, the need to protect medical devices from cyber threats has become increasingly...

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The Affinial Digital Health Platform – Cybersecurity and Keeping Patient Data Safe
August 29, 2023 John Mulcahy

Cybersecurity is an essential consideration for pharma companies creating digital health solutions and connected devices because these...

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What’s changed in cybersecurity – and how medtech needs to respond
June 1, 2022 John O'Gorman

Cybersecurity has become an essential consideration for medtech. I discussed the basics in my last blog, where I expanded on how...

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