One question we at Hardian get asked a lot is how to classify products for regulatory purposes that take an input from a sensor, and then process that signal using software. The answer depends on the intended purpose of the sensor, and the intended purpose of the output.

Launching an AI medical device startup is an adventure but with escalating costs threatening to slow your progress, the path to your first sale appears steep. We look at how you can get reimbursement for your AI medical device before regulatory approval.

The new MindSet XR ecosystem for UK innovators working on immersive digital mental health therapeutics has been launched, including Hardian Health as a regulatory partner.

Expertise is needed to conduct thorough due diligence in the highly regulated and evidence-based healthcare sector. Hardian covers key clinical and regulatory points when conducting DD for investors, mergers, or acquisitions of an SaMD or AIaMD company.

Learn how to derive the documentation requirements for SaMD from the safety and risk class of the device and download a free cheat sheet to help you navigate regulatory submissions.

Through our extensive experience of regulatory submissions for SaMD the top five make-or-break success factors are Design Control, Requirements Management, Risk Management, Verification and Validation evidence, and Software Maintenance under Change Control.

Software as a Medical Device is getting easier to build. Because of this many hospitals and other healthcare providers are now developing their own software and AI medical devices in-house to serve their patients. Learn how health institution exemptions might apply to your in-house SaMD or AIaMD in Great Britain.

Wearable devices, such as bracelets, patches, smartwatches, and virtual reality goggles are taking center stage in the digital healthcare revolution. In this article we take a look at how wearables and associated apps are regulated in the EU.

We hosted our second annual Healthtech Summit, bringing together a diverse community of healthtech leaders to share their stories and learn from each other.

Advertised as a 90 day process, we analysed the data to find out how long it really takes for manufacturers to receive their 510(k) clearance.

If you currently have a UKCA or CE marked medical device on the market you should anticipate unannounced audits to be conducted on your organisation. We explain what they are and how you should be preparing for them.

From ChatGPT to deepfakes, AI development is rapidly progressing. In reaction to the current landscape of AI the European Commission is setting a standard with its new approach to AI regulation through the introduction of the EU Artificial Intelligence Act.

ISO standards are designed to help businesses ensure that their products and services meet a certain level of quality, safety, and effectiveness. Healthtech has its own standards that organisations may need to conform to, here are the ones that you need to know and where you can find them.

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?

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.

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.

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.

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 .