British firm AND Technology Research has developed a generative AI, Tento+, to speed up the medical compliance process for healthcare devices. The company claims it is the first generative AI system designed specifically for medical device compliance. The new system can accelerate regulatory approval, and help keep approved devices compliant. ANDtr calculates its new AI saves around 236 hours of work in the average medical device regulatory submission.

The new AI has been fine-tuned with expert input, and tested on hundreds of medical devices. It is able to accelerate authoring and safety reviews in the device regulatory approval process.

The tool allows users to enter a brief device description, and then provides tailored insights and suggestions for design requirements, test plans, and more. Users can also understand automatically which design standards apply to their device, and generate automated checklists that are required.

In a recent trial of 5 projects using Tento+, the AND Technology Research team was able to calculate how much time Tento+ can save a company when working through the medical submission regulation process. They found that the average medical compliance project can save 236 hours by using the new platform.

Users will also be able to capture and analyse certain technical, risk and clinical information directly in Tento+. Users will then be able to record traceability matrices, testing records and anomalies as well as risk and usability controls. From here, users can automatically generate technical documentation such as test plans, test logs and records, software decompositions and software requirements for use within submissions to regulatory bodies.

The Tento+ dashboard is a web-based tool that enables developers, project managers, QR, and test engineers to track, manage, and organise their product development and testing journey. The dashboard is designed to provide engineers with quick insights into the progress of their project as test scripts, anomalies, and the requirements traceability matrix are all accessible in one place.

Commenting on the launch of Tento+ and the trial findings, CEO of Tento+, Dr Nicola Thorn said: “The potential of generative AI in medical compliance is enormous. From authoring content to assessing changes on a device, the generative AI is the first tailored to the world of medical compliance. It is fine-tuned with expert input and tested on hundreds of devices. This is proving to be a genuine game changer!”

“So many innovators and engineers struggle in navigating the regulation process and not knowing where to start. This no longer has to be the case. There are many hurdles, so many complex considerations to make, and it bleeds businesses’ time and money. This is where the power of generative AI comes in. Tento+ has always offered a simple platform, that aides and speeds up management of design control process. And now, our algorithm means that the whole of Tento+ is tailored directly to your device, specifically generated for your product.”