AND Technology Research has launched a generative artificial intelligence (AI) dashboard update to its medical compliance tool, Tento+.
The new update is designed to streamline the medical compliance process. As per AND Technology, the Tento+ AI can save around 236 hours of time per submission.
The average time from device conception to approval is about three to seven years. The World Health Organisation (WHO) estimates that there are around two million different medical devices currently on the market, and these are increasing exponentially.
The built-in set of tools in Tento+ is designed to support compliance requirements. The users enter a brief description of the device, and the tool then generates the device design standards and automated checklists.
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“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,” said Tento+ CEO Dr Nicola Thorn. “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 aids 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.”
Tento+ also provides design requirements and test plan suggestions along with tailored insights into these fields.
Dr Thorn told Medical Device Network that the tool also provides additional functions, stating “Tento+ will not only provide an easy way for medical device manufacturers to manage design and risk controls, but Tento+ will also soon boast a comprehensive clinical suite that allows users to: define safety and effectiveness endpoints; capture clinical and usability protocols; and record testing outcomes and results.”
She adds that “endpoints will be easily linked to the risk-benefit analysis as well as specific risks to show that a device is both safe for use and provides a clinical benefit. Like all Tento+ modules, a personalised AI assistant, GeMA, will also generate state-of-the-art guidance to help plan and formulate protocols that would be required to cover the intended use.”