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Is the US 510(k) process robust enough for AI?
Substantial equivalence of AI systems cannot be reliably proven through technological, safety nor effectiveness characteristics, so is the US 510(k) process robust enough for AI?
How to Level Up to Digital Therapeutics 2.0
Health technology suffered several setbacks the last few months, culminating with Pear Therapeutics recently filing for bankruptcy. Now it’s time to take stock, regroup and work to usher in the next generation of digital therapeutics.
How to get ChatGPT regulatory approved as a medical device
The advent of ChatGPT and similar large language models has created unprecedented excitement for their application in medicine. We explore how it might be possible to use LLMs such as ChatGPT in medical practice under current medical device regulatory frameworks.
5 questions you need to answer to get your digital health or AI software product to US market quicker
When it comes to taking health innovation to the US, digital health companies need to be armed with robust clinical evidence to achieve approval from the Food and Drug Administration (FDA). We share 5 questions that you need to consider from the offset, that will maximise your chances of securing FDA regulatory approval and landing your product on US soil faster.
Understanding IEC 62304 requirements for medical device software
IEC 62304 is an international standard that defines the lifecycle requirements to develop Software as a Medical Device (SaMD) such that once deployed it is safe, effective, and cybersecure .
Will Apple & Google tame the health app wild west??
Apple and Google’s app stores have new roles in the health and wellness app sector. These companies should comply with new EU medical device regulations and digital EU laws to resolve a cycle of conflicts that currently prevent them from fulfilling their legal obligations.
5 common mistakes in SaMD and AI Quality Management Systems
Learn about the five common mistakes that software as a medical device and AI companies regularly make, which they are perhaps unaware of, or that often go unnoticed until spotted by an external auditor.
All I Want for Christmas is… Reliable AI
AI-enabled health tech has had its share of ups and downs over the past few years. Hardian breaks down the obstacles and solutions to moving the space forward.
NICE ESF & Hardian: The perfect recipe for bringing healthtech to market
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).
A guide to FDA Diagnostic Radiology Product Codes
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.
Hardian Health Tech Summit: Lifting the veil on the realities of getting healthtech to 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.
What is The Medical Device Single Audit Program (MDSAP)?
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.
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.
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.