TLDR: NICE ESF is a set of standards that digital health technologies should adhere to to be commissioned by the NHS and care system. Set yourself and your solution up for success by using ESF as a guide to demonstrate the clinical effectiveness and cost-benefit evidence ready for NICE health technology assessment (HTA).

When it comes to the US market, three-letters stand in the way of getting your products to market. FDA Product Codes are essential in understanding and classifying your medical device. We breakdown FDA product codes for diagnostic radiology AI devices currently available on the market.

To celebrate four years of client service, we held our very first Hardian Health Tech Summit event. Joined by many of our clients changing the game in the healthtech industry and keynote speakers from MHRA and NICE, we brought together a community of healthtech leaders for everyone to connect, share and learn.

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.

Your guide to Good Machine Learning Practice within regulatory frameworks

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.

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