The Medical Device Single Audit Program (MDSAP) provides medical device manufacturers with a single compliance certification based on essential standard and regulatory requirements for their quality management systems (QMS) in five major markets: Australia, Brazil, Canada, Japan and the United States.

Whether you are a clinician, academic, or work in healthtech, systematic literature reviews can be an intensive task. We empathise with you! Find out more on best practices and strategies.

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 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.

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.

'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.

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.

Your guide to Good Machine Learning Practice within regulatory frameworks

Hardian Health announces partnership with Aidence and the University of Edinburgh to evaluate Veye chest under the NHS AAC Award.

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.

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.

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.

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.

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? If you assume the answer is no, you could well be missing out on commercially valuable protection. Find out more…

Find out how the new UKCA regulatory changes will affect medical device companies on a global scale.

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.

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.