Insights
SaMD Literature Reviews Made Simple
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.
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.
MHRA/FDA Principles of Good Machine Learning Practice
Your guide to Good Machine Learning Practice within regulatory frameworks
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 wouldnβt blink an eye about such a mundane and bureaucratic process - but actually, thereβs some serious ramifications.
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.
UKCA β 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.
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. Youβll need experts in both.
Beware the COVID-tech Cowboys
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.
The Story of Radiology AI
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.