MyCardium AI is a rapidly growing UK-based company delivering advanced core-lab services, now with two CE-marked and FDA-cleared AI medical devices - 1CMR Pro and EchoConfidence - built on decades of leading academic research. With Hardian Health as a strategic partner, MyCardium navigated complex regulatory pathways with exceptional speed and success. How did they do it?

Many healthcare software products are described as “platforms.” But when it comes to Software as a Medical Device (SaMD), regulatory challenges quickly emerge. From classification to conformity assessments, platforms that host or enable MDSW apps—particularly those involving AI—must navigate complex and evolving frameworks across jurisdictions like the UK and EU.

SaMD regulatory requirements are fast evolving, with international efforts to harmonise frameworks still taking shape. Yet manufacturers must navigate jurisdiction-specific rules—especially as the US aligns more closely with ISO 13485:2016 in its Quality System Regulation. Whether you're targeting EU, US, or emerging markets, understanding the SaMD regulatory landscape is a critical first step.

Recently, we hosted an exclusive webinar featuring Dr Vera Roedel (CEO) and Professor Heinz Wiendl (Co-Founder) from Prof.Valmed®. They have achieved the significant milestone of securing the world's first regulatory clearance for a large language model (LLM) as a medical device.

Do AI medical devices need clinical data for CE mark? Many teams building AI that predicts, measures, prioritizes, or triages ask whether prospective clinical data is required under the EU MDR. Dr Ankeet Tanna outlines when clinical investigations are essential, when indirect clinical benefit and non‑clinical evidence can be enough.

Buying AI-triage software isn't like purchasing regular tech. These tools are medical devices with strict regulatory requirements. Our guide (co-produced with Visiba Group) breaks down everything you need to know…

From scribes and image analysis to triage, diagnosis, and treatment planning, the technical capability emerging from startups is already there. What’s less clear is a credible plan for how these tools will enter regulated clinical markets - and remain there.

While regulatory developments in the US, UK, and EU, such as the FDA’s AI January 2025 draft guidelines and the EU’s AI Act, have set prominent benchmarks, significant innovation and diverse regulatory strategies are evolving rapidly across Asia, Africa, and South America.

ISO and IEC standards are applicable to every industry, not just healthtech. But healthtech has its own standards that SaMD and AIaMD developers need to conform to.

Following on from previous blogs, What you need to know about traceable requirements for medical devicesand How much documentation does my Software as a Medical Device regulatory submission really need?, it’s time to now think about how to organise the complementary risk management, particularly for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD).

Anyone dealing with regulatory hurdles goes through the same 5 stages - denial, anger, bargaining, depression and acceptance. Here's how to smooth the journey.

In an industry where patient safety and regulatory compliance are non-negotiable, making unverified or misleading claims isn’t just bad practice – it can lead to hefty fines, product recalls, and serious reputational damage.

Once a device has been approved by an approved body in the UK, the question then becomes, how can a member of the public find out if a device is approved for use, and what it is approved for? Indeed, can we find out how many AI medical devices are actually on the market in the UK?

In part 1, we outlined the key concepts of a quality management system (QMS), explored what a QMS is – and what it is not – discussed why a QMS is required by law and who needs it, and provided an overview of the structure of a QMS. Now, in part 2, we'll move on to the practical side of implementing and managing a QMS effectively. Now then, back to Kipling’s six honest men…

Last month we hosted our third Health Tech Summit, bringing together our healthtech community at the London Institute for Healthcare Engineering for an afternoon filled with engaging discussions, expert insights, and canapés with a view!

As AI is increasingly integrated into more and more medical devices, the regulations and standards are also maturing and developing. Often we get asked ‘What are the most important standards we need to know?’, so here is the definitive list.

QMS. Three simple letters that often instil fear and dread into healthtech developer’s minds. It needn’t be that way! A well-designed Quality Management System will not only ensure your company is compliant with the relevant legislation, it will actually enhance and improve your internal processes so that your whole team feels in control of the quality of your products.

Find out how Hardian is supporting Innovate UK’s Mindset Extended Reality (XR) for digital mental health programme as part of Health Innovation Network (HIN) South London’s consortium of experts.