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Daniel Mannion

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Daniel brings extensive expertise in UKCA marking, CE marking and CE certification of Software as a Medical Device (SaMDs), In Vitro Diagnostics (IVDs), and Medical Devices, garnered from four health-tech medical device companies. His career spans numerous successful implementations and remediations of management systems. He collaborates cross-functionally with businesses, facilitating the development of tailored, robust management systems for health-tech companies. These systems are meticulously crafted to ensure effectiveness, durability, and seamless readiness for certification and audits. With a profound understanding of global medical device regulations, Daniel has formulated and executed comprehensive medical device strategies tailored for European, American, Middle Eastern, Asian, and Australasian markets. His expertise extends to providing invaluable support and guidance on regulatory strategies and interactions with regulatory bodies. Daniel is an active participant in various standardisation and harmonisation panels. His commitment stems from the belief that enhanced guidance fosters the development of superior health tech products and services, aligning with his vision for advancing the industry’s standards and practices.
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Blog post: How I learnt to keep worrying, but embrace Google Gemini anyway
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Daniel Mannion

How I learnt to keep worrying, but embrace Google Gemini anyway

Posted In: Cyber Security
Published: July 15, 2026
At this point, most organisations have probably had the conversation. Someone in your team has tried ChatGPT. Someone else has raised concerns...
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FAQ: What is a Technical File?
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Daniel Mannion

FAQ: What is a Technical File?

Posted In: Medical Devices
Published: May 9, 2026
Key facts about Technical File Creation If you are developing a medical device, the "Technical File" (or “Technical Documentation” in some regulations)...
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Title graphic reading 'Making sense of AI in Healthcare: Why we built 8fold Training'
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Daniel Mannion

Making sense of AI in Healthcare: Why we built 8fold Training

Posted In: Artificial Intelligence
Published: April 20, 2026
AI is moving quickly in healthcare. New tools, new use cases, new expectations. For many teams, the opportunity is clear. So is...
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AI isn’t special
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Daniel Mannion

AI isn’t special

Posted In: Artificial Intelligence
Published: February 19, 2026
Artificial intelligence is increasingly part of the conversation about very real pressures in the NHS, from workforce shortages to rising demand and...
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qmsr
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Daniel Mannion

Expert Insights: What does QMSR mean for developers of SaMD?

Posted In: Medical Devices
Published: January 25, 2026
What SaMD Teams Need to Know The FDA’s new Quality Management System Regulation (QMSR) comes into effect on 2nd February 2026. Thisreplaces...
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DSPT for Category 2 Organisations
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Daniel Mannion

DSPT for Category 2 Organisations

Posted In: DSPT
Published: December 13, 2025
Key Changes to Essential Data Protection & Information Security Standards in the NHS The NHS Data Security and Protection Toolkit (DSPT) is...
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AI and Medical Devices: What is BS/AAMI 34971?
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Daniel Mannion

AI and Medical Devices: What is BS/AAMI 34971?

Posted In: Medical Devices
Published: April 10, 2025
What is BS/AAMI 34971? BS/AAMI 34971:2023 is a joint standard developed by the British Standards Institution (BSI) and the Association for the...
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FAQ: Software as a Medical Device: What you need to know
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Daniel Mannion

FAQ: Software as a Medical Device: What you need to know

Posted In: Medical Devices
Published: March 31, 2025
Introduction Software as a Medical Device (SaMD) has become a crucial component of modern healthcare, providing innovative solutions for diagnosing, monitoring, and...
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IEC 62304
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Daniel Mannion

IEC 62304 Edition 2 – Big changes in SaMD requirements

Posted In: Medical Devices
Published: March 10, 2025
Introduction to IEC 62304 IEC 62304 is the international standard for software development and testing of medical device software that is well-recognised...
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Expert Insights: Developing Medical Device Quality Management Systems for International Growth
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Daniel Mannion

Expert Insights: Developing Medical Device Quality Management Systems for International Growth

Posted In: Medical Devices
Published: February 28, 2025
ISO 13485, 21 CFR 820, QMSR and MDSAP. Medical Device Regulators agree on a lot of the requirements for a manufacturer to...
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Daniel Mannion

Post Market Surveillance – UK MDR 2024 – What you need to know

Posted In: Medical Devices
Published: December 3, 2024
A major update to UK Medical Device Regulations 2002 was recently laid before parliament, starting the process for a 2024 update to...
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ISO 13485
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Daniel Mannion

What is ISO 13485?

Posted In: International Standards
Published: October 23, 2024
ISO 13485 is an international standard used by Manufacturers of Medical Devices to help design a Quality Management System (QMS). It was...
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Daniel Mannion

Expert Insights: Are International Standards truly “International”?

Posted In: Expert Insights
Published: October 18, 2024
Understanding Regulators expectations for Medical Devices International Standards are the sources of best practice for Medical Device manufacturers to help ensure their...
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The Latest Guidance for AI and Machine Learning in Medical Devices V3
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Daniel Mannion

The Latest Guidance for AI and Machine Learning in Medical Devices V3

Posted In: Artificial Intelligence
Published: September 9, 2024
We’re back once again with more important updates on the ever-evolving guidance on AIaMD. If you’ve missed the previous Versions of this...
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Expert Insights: How to prevent a CrowdStrike scenario in healthcare
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Daniel Mannion

Expert Insights: How to prevent a CrowdStrike scenario in healthcare

Posted In: Industry Insights
Published: August 13, 2024
On 19 July 2024, people across the world woke up to find their IT equipment was completely unusable - crashing and unable...
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The Latest Guidance for AI and Machine Learning in Medical Devices V3
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Daniel Mannion

The Latest Guidance for AI and Machine Learning in Medical Devices V2

Posted In: Medical Devices
Published: June 17, 2024
It’s been two months since the first version of this document was published (see our Blog) and as expected, there’s already been...
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A Competitive Advantage: How ISO Standards align with the NHS DTAC
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Daniel Mannion

A Competitive Advantage: How ISO Standards align with the NHS DTAC

Posted In: International Standards
Published: May 13, 2024
When healthcare innovators understand and can evidence compliance with international standards, the path to a successful DTAC is much simpler and cost...
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The Latest Guidance for AI and Machine Learning in Medical Devices V1
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Daniel Mannion

The Latest Guidance for AI and Machine Learning in Medical Devices V1

Posted In: Medical Devices
Published: April 22, 2024
AI Medical Devices (AiMD) and Software as Medical Devices (SaMD) manufacturers can speed up approvals and develop safer and more effective technology...
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How ISO 14971 helps to meet DCB0129
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Daniel Mannion

Expert Insights: How ISO 14971 helps to meet DCB0129 (and vice versa)

Posted In: Expert Insights
Published: January 17, 2024
By Karen Whitton, Director of Clinical Risk, and Daniel Mannion, Head of Quality Assurance and Regulatory AffairsNavigating the intricacies of risk management...
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