ISO 14971 has been central to medical device risk management for over two decades. It provides a structured and defensible methodology: identify hazards, analyse hazardous situations, estimate and evaluate risk, implement controls, and determine whether residual risk is acceptable in light of clinical benefit.

Science washing in digital health can damage trust and trigger regulatory scrutiny. Learn how to communicate evidence responsibly and build credibility.

In July 2025, the FDA issued a warning letter to WHOOP, stating that measuring blood pressure is a medical device function. But in January 2026, they updated their guidance. What changed? Do the new guidelines really allow wearables to measure blood pressure without regulation or evidence?

It’s been 4 years since the FDA updated their CDS guidance. The new 2026 version brings clarification, more examples, and some pragmatic relaxation of how to interpret the CDS criteria. But are the changes really that substantial?

Many countries around the world currently have no central database of their medical devices, or have ones that are not quite fit for purpose. We are building HaRi - a global regulatory intelligence database - bringing medical device regulatory data into modern era of innovation. Our hope is that by raising the veil of transparency across all medical devices, the entire industry can benefit.

We're witnessing a rapid rise of the use of generative AI in the medical device regulatory space to produce and review documentation. This raises the question - If all compliance documentation is created by a machine, and all compliance documentation is audited by a machine - has any compliance actually happened?

Hardian team members Lucy Gregory (Health Economics Consultant) and Dr Felicity Lock (Senior Clinical Associate) recently returned from ISPOR Europe, an international conference in Glasgow dedicated to Health Economics and Outcomes Research. If ISPOR is unfamiliar territory, this overview explains why it should matter to anyone developing AI and software as a medical device.

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?

For digital health innovators, the NHS can seem like a maze. It’s vast, decentralised, and full of confusing acronyms. But behind that complexity is a set of real people, teams, and incentives that, once understood, can help shape the routes to market access.

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.

Around a quarter of doctors are already using generative AI. But are they using it safely? Here's what healthcare professionals need to know.

Many startups rush to build products without deeply understanding NHS problems. This leads to poor adoption, even when the technology is strong. To succeed, you need to ensure your product solves a real NHS problem, one with clear unmet needs, decision-makers, and budget pathways.

Sanome has reached a landmark moment with the CE Marking of its AI-powered clinical decision support tool, MEMORI, as a Class IIb medical device. This makes it the first UK-built AI tool certified to tackle hospital-acquired infections—a major step forward for clinical AI and infection prevention.

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.