Insights
NICE ESF: The what, when and how?
The UK's National Institute for Health and Care Excellence (NICE) released the latest evidence standards framework (ESF) for digital health technologies (DHTs). It's easy to see how standards updates can be confusing, however this update is an important one, and benefits everyone across the industry, from developers, through to healthcare services and patients.
Autonomous Radiology AI - too good to be true?
Autonomous AI is finally here - or is it? A recent breakthrough IIb regulatory approval raises questions, and perhaps sets the scene for upcoming legislative changes to how healthcare is practiced.
Rethinking regulation, with Neuronostics
Hardian supported Ross Parkman, Technical Director at Neuronostics, a company on a mission to improve the lives of people with epilepsy to gain their initial CE mark.
Re-imagining information and outcomes in healthcare
'Personalised medicine' is accelerating in clinical interventions (e.g. in genomics, pharmaceuticals, surgical implants and synthetic organoids). Now it's time to think about 'personalised medicine' in terms of the data we use to make clinical decisions and measure outcomes.
Tools for AIaMD Transparency and Reporting
Transparency around AI is the first step to building trust, but we still have some way to go to earning that trust in medical AI.
MHRA/FDA Principles of Good Machine Learning Practice
Your guide to Good Machine Learning Practice within regulatory frameworks
Hardian and Aidence partner with University of Edinburgh for NHS AI Award.
Hardian Health announces partnership with Aidence and the University of Edinburgh to evaluate Veye chest under the NHS AAC Award.
Spotlab’s software IVD CE marking story
Hardian worked closely with Miguel, co-founder of Spotlab and Adriana, Spotlab’s biomedical engineer and regulatory affairs manager to assist them with CE marking for their software IVD.
Navigating EU medical device regulation, with Koios Medical
Hardian supported Koios Medical to help their CEO Chad and this American team to navigate the minefield that is EU medical device regulation, and gain a footing here in Europe with a Class IIa CE mark.
UK medical device regulations - where are we headed?
The UK Regulatory Horizons Council recently published their report on the possibilities of UK medical device regulations after Brexit. Normally, any sane person wouldn’t blink an eye about such a mundane and bureaucratic process - but actually, there’s some serious ramifications.
How Hardian helped Koios convert their FDA approval to CE marking
The US FDA and the EU MDR, while ostensibly serving the same purpose of vetting and clearing novel medical devices, do so in subtly different ways. What got you here, won’t get you there - learn more about converting from one regulatory system to another.
The ultimate guide to UKRP from Jan 1st 2021
Brexit is here, for better or worse. And that means changes to how international manufacturers of software-based medical devices must register with the MHRA.
Can you patent an algorithm? Our IP lawyer explains how
Can you patent an algorithm? If you assume the answer is no, you could well be missing out on commercially valuable protection. Find out more…
UKCA – What does it mean for medical device companies?
Find out how the new UKCA regulatory changes will affect medical device companies on a global scale.
Investment Ready IP
For investors looking at a health technology business, their intellectual property position will play a significant role in any decision to invest. Find out more on how to protect your IP and satisfy investors.
Digital health - Strategy or Fantasy?
The worst person you can fool about your product’s value is yourself. It’s time to take a reality check on the feasibility and risks of your grand idea.
5 simple questions to ask clinical AI vendors before you buy
Learn the five key questions you need to ask AI vendors, giving you the low-down on common marketing misunderstandings, statistical obfuscation, and creative stretching of medical device regulation.
Want a safe medical device? You'll need hands-on clinicians
For innovative health technology, the only route to market is regulatory approval. The only route to regulatory approval is clinical evidence. You’ll need experts in both.