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.

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.

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.

Health tech has suddenly found its new focus in Coronavirus - but are we at risk of doing more harm than good by rushing to use unproven solutions? To avoid chaos in the aftermath, we should focus on tried-and tested tech, and only use novel solutions where need is deemed greater than the acceptable risk.

How do you build an AI company in healthcare? What can AI in radiology actually do? What should it be doing? Are clinicians ever going to be replaced? What does the future look like in healthcare AI?

In this HS Health Tech podcast, James is joined by Dr. Hugh Harvey, Managing Director at Hardian Health.