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Hands-on or Hands-off? Outsourcing MDR/510(k) Work
Most MedTech founders treat outsourcing their cybersecurity evidence as a single switch: build it all…
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Preparing AI-Enabled Medical Devices for EU MDR: Building Evidence Around the Right Regulatory Questions
Author: Ronghe Xu Ronghe Xu is a Regulatory Medical Writer at Mantra Systems. Her work…
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Security and Governance Evidence for AI Features
Cyber Alchemy × Mantra Systems | Episode 4 This article is published in partnership with Mantra…
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Who Does Cyber Alchemy Serve?
Cyber Alchemy works with organisations where cybersecurity is no longer a background IT concern. It…
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What is a vCISO, and does your business need one?
Written by Cyber Alchemy Most businesses that need a vCISO do not realise it. Security…
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How to Handle Notified Body Non-conformities and get Back on Track
Written by: Will Brambley, Lead Medical Writer Cyber Alchemy × Mantra Systems — Episode 2 This article is…
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EU MDR, FDA 510(k) and NHS DTAC
How Cybersecurity Nonconformities Happen, and How to Recover Cyber Alchemy × Mantra Systems — Episode 2…
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Where to Launch First? A MedTech Founder’s Regulatory Roadmap to the EU, UK and US
This article is published in partnership with Mantra Systems. Their focus is on cybersecurity, helping teams…
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Essential Guide to SaMD and Medical Device Security: Free Guide
Accessing the healthcare market now depends on more than clinical performance alone. Medical device and…
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About
Neil Richardson
I am the co-founder and partner of Cyber Alchemy LTD and an associate lecturer in the computing department at both Sheffield Hallam University and The University of Warwick.
