Post-Quantum Cryptography and Cybersecurity for Medical Devices

In this Issue

From the Editor ✍🏽 | In Brief 💥 | What's Happening 🗓️ | Featured Post 📌 | Sections ✅ | Postscript 🐝

From the Editor ✍🏽

📌 Featured Posts: Special thanks to Jose Bohorquez , Jason D. , and Ian Gauci for their insightful posts on cybersecurity and to Mark Omo for sharing his free tool for evaluating post-quantum cryptography for medical devices. Who knew?

🔥 Plus ten more super-useful new posts, Martin King’s Regulatory Roundup, and the latest 510(k) Clearances from Marcus Engineering, LLC.

Featured Webinar - Article 10a

Please join subject matter experts Bassil Akra, Erik Vollebregt, and Lawrence Yeh on Tues., Dec 17, for "What You Need to Know About Article 10a Before January 10, 2025."

Register Now!

In Brief 💥

In no special order...

• Jose Bohorquez explained why, in cybersecurity, you need to be right 100% of the time.
• The latest updates to the Australian Regulatory Guidelines for Medical Devices (ARGMD) were shared by Mike B. W., highlighting key compliance information for Australia.
• Stefano Bolletta detailed the European Commission’s report on Article 17 of the EU MDR, focusing on the reprocessing of single-use devices.
• Marina Daineko highlighted the FDA’s report on risks and benefits of non-device software functions and strategies to reduce reliance on EtO sterilization.
• 12 key facts about PRRC under MDR/IVDR were shared by EU MDR Compliance, offering critical insights for compliance officers.
• Georg Digel outlined the 8 essential skills for effective CAPA management, emphasizing the importance of quality systems.
• A priority framework for managing incoming regulatory updates was presented by Tibor Zechmeister to guide teams on staying compliant.
• Michelle Lott, RAC, explored developing scientific evidence for safety and efficacy, a critical commercialization step.
• TÜV Rheinland Medical Devices shared insights on requirements for home-use medical devices under MDR and IEC 60601-1-11, emphasizing safety and compliance.
• A primer on software development for medical devices was shared by gener8, focusing on key aspects of IEC 62304 compliance.
• Jason D. emphasized the importance of aligning with the FDA’s Premarket Cybersecurity Guidance to enhance trust in medical device security.
• Cybersecurity and liability in the digital age of medical devices were discussed by Ian Gauci, highlighting a new era of accountability.
• Mark O. asked the question: Are your devices ready for post-quantum cryptography? Emphasizing future-proofing strategies.
• Bassil Akra shared 7 key things to know about Article 10a before January 10th.

Four Featured Posts 📌📌📌📌

📌 What is post-quantum cryptography, and why should you care?

Mark Omo breaks it down: quantum computers are advancing fast, and outdated cryptography risks obsolescence as soon as 2030. Learn how to future-proof your devices and ensure they’re ready for a post-quantum world. Try his free tool to evaluate your device’s readiness!

📌 In cybersecurity, you need to be right 100% of the time

In a short video post, Jose Bohorquez explained why cybersecurity in MedTech is no joke. Every single connection—wired or wireless—can be a target for hackers. Even “offline” devices with ports or chips can be exploited, leading to stolen data, ransom demands, or network breaches. Don’t let your medical device become a gateway for cyberattacks. Secure it. Always.

📌 Are You Ready to Turn Compliance Into a Competitive Edge?

Jason D. shared a new article about why the FDA’s premarket cybersecurity guidance is more than a checklist—it’s your roadmap to trust and market leadership. By embedding cybersecurity into every stage of your product lifecycle, you can protect patients, exceed expectations, and differentiate your brand. Read the full article.

📌 Welcome to the New Era of Cybersecurity and Medical Device Accountability

Ian Gauci highlighted the EU’s evolving regulatory landscape, where frameworks like the Cyber Resilience Act, NIS2 Directive, and AI Act join the MDR and IVDR to ensure safety, accountability, and innovation. From liability for defective AI to enhanced cybersecurity, this is a must-read for MedTech leaders. Read the full article.

Sections ✅

Regulatory Roundup by Martin King - Week of December 9

Featuring the latest regulatory updates from: 📌 𝘈𝘕𝘝𝘐𝘚𝘈 𝘉𝘳𝘢𝘻𝘪𝘭📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘊𝘰𝘮𝘮𝘪𝘴𝘴𝘪𝘰𝘯📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘋𝘪𝘳𝘦𝘤𝘵𝘰𝘳𝘢𝘵𝘦 𝘧𝘰𝘳 𝘵𝘩𝘦 𝘘𝘶𝘢𝘭𝘪𝘵𝘺 𝘰𝘧 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 & 𝘏𝘦𝘢𝘭𝘵𝘩𝘊𝘢𝘳𝘦📌 𝘌𝘶𝘳𝘰𝘱𝘦𝘢𝘯 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘏𝘦𝘢𝘭𝘵𝘩 𝘚𝘤𝘪𝘦𝘯𝘤𝘦𝘴 𝘈𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘺 (𝘏𝘚𝘈), 𝘚𝘪𝘯𝘨𝘢𝘱𝘰𝘳𝘦📌 𝘐𝘚𝘖 (𝘐𝘯𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘖𝘳𝘨𝘢𝘯𝘪𝘻𝘢𝘵𝘪𝘰𝘯 𝘧𝘰𝘳 𝘚𝘵𝘢𝘯𝘥𝘢𝘳𝘥𝘪𝘻𝘢𝘵𝘪𝘰𝘯)📌 𝘐𝘯𝘵𝘦𝘳𝘯𝘢𝘵𝘪𝘰𝘯𝘢𝘭 𝘊𝘰𝘶𝘯𝘤𝘪𝘭 𝘧𝘰𝘳 𝘏𝘢𝘳𝘮𝘰𝘯𝘪𝘴𝘢𝘵𝘪𝘰𝘯📌 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦𝘴 𝘢𝘯𝘥 𝘏𝘦𝘢𝘭𝘵𝘩𝘤𝘢𝘳𝘦 𝘱𝘳𝘰𝘥𝘶𝘤𝘵𝘴 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘈𝘨𝘦𝘯𝘤𝘺📌 𝘚𝘸𝘪𝘴𝘴𝘮𝘦𝘥𝘪𝘤📌 𝘛𝘦𝘢𝘮 𝘕𝘰𝘵𝘪𝘧𝘪𝘦𝘥 𝘉𝘰𝘥𝘺, 𝘌𝘶𝘳𝘰𝘱𝘦📌 𝘛𝘩𝘦𝘳𝘢𝘱𝘦𝘶𝘵𝘪𝘤 𝘎𝘰𝘰𝘥𝘴 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 (𝘛𝘎𝘈), 𝘈𝘶𝘴𝘵𝘳𝘢𝘭𝘪𝘢📌 𝘜𝘚𝘈 𝘍𝘰𝘰𝘥 & 𝘋𝘳𝘶𝘨 𝘈𝘥𝘮𝘪𝘯𝘪𝘴𝘵𝘳𝘢𝘵𝘪𝘰𝘯 𝘍𝘋𝘈📌 𝘞𝘰𝘳𝘭𝘥 𝘏𝘦𝘢𝘭𝘵𝘩 𝘖𝘳𝘨𝘢𝘯𝘪𝘴𝘢𝘵𝘪𝘰𝘯 𝘞𝘏𝘖

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✅ 510(k)s at a Glance for the week of December 9, 2024

Marcus Engineering, LLC highlighted 66 new FDA 510(k) cleared devices last week, including 14 first-time clearances. 🚀

For full details, visit Marcus Engineering’s report.

🗓️ What’s Happening

• Tuesday, Dec. 17 - "What You Need to Know About Article 10a Before January 10, 2025," with subject matter experts Bassil Akra, Erik Vollebregt, and Lawrence Yeh.
• Tuesday, Jan. 21 - Join Richard Holborow , Nebojsa Serafimovic , and Matthias Fink for a panel discussion on Orphan Devices in the EU. Register Now!

Postscript 🐝

In case you missed it - US MedTech Market Access: Strategic Outlook 2025, featuring speakers Edward Dougherty and Richard Piquett, is now available on replay.

Sean