LONDON – One of the first companies to successfully introduce real-world Artificial Intelligence benefits for NHS patients has achieved the gold standard of quality certification.
Behold.ai, headquartered in London, is delivering its algorithm-based ‘instant triage’ in the radiology department at Dartford and Gravesham NHS Trust where patients have already benefited from its ability to quickly identify anomalies in multiple-modality scans. The ground-breaking software is also currently live in two other NHS Trusts.
It has now been awarded ISO 13485 QMS certification – after adopting a ground-breaking approach to achieve the Standard that had been specified long before recent developments in AI algorithms.
Mike Harrison, behold.ai’s Global Director of Compliance, pointed out that the organisation, founded by former CEO of Medica Group Simon Rasalingham in 2017, achieved certification-ready status in a relatively short period of time after it made a huge company-wide commitment.
“In order to do so, we had to have complete buy-in from everyone in the business and there was a huge amount of team work involved. I think this demonstrates that Simon has put together a very well balanced team that together achieves more than the sum of its parts. This is an especially difficult thing to do when staff are based in multiple continents!
“An ISO 13485 QMS is a lot more complex than a ‘traditional’ ISO 9001 QMS. Specifically focussed on companies that build Medical Devices, it includes all of the requirements of ISO 9001 and adds a whole host of extra requirements to ensure that the company can build Medical Devices that are both clinically safe and clinically effective. So it was a huge amount to learn and it brought the company to operational ‘maturity’ in a very short space of time. It has provided the business with a very solid foundation on which to grow and develop”.
Mr Harrison revealed that the advanced nature of the algorithm itself had set the team unusual challenges.
“When reading these Standards, it soon becomes obvious that they were written before Artificial Intelligence was considered a Medical Device; so a lot of creative abstraction of concepts and ideas was required in order to build a QMS that was effective for our business whilst at the same time meeting the necessary requirements.
“The audit itself was 7 man-days long and no area of the business was left unexamined. So I really feel that this is a glowing endorsement of the company and of the team that Simon has put together”.
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NOTES FOR EDITORS
Behold.ai is headquartered in London and has corporate and research facilities in New York and India.
ISO 13485 is essential for behold.ai’s ambitions to develop products in the UK/EU. It is widely anticipated that the FDA will adopt ISO 13485 in place of their existing 21 CFR 820 QMS standard – so it will become essential for the company’s ambitions in the US market.
When looking for a certification body, Behold chose BSI which is regarded as the gold standard UKAS accredited certification body in the UK.
ISO 13485 specifies requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is the internationally-recognised gold standard for quality in the medical device industry.
Behold.ai utilise cutting-edge science to pioneer new forms of diagnostic medicine; this innovative approach to healthcare is a step change in the treatment and prevention of diseases, delivering benefits today to patients across the NHS.
Behold.ai provides artificial intelligence, through its red dot® cognitive computing platform, to radiology departments. Behold.ai’s technology augments the expertise of radiologists to enable them to report with greater clinical accuracy, faster and more safely than they could before. This revolutionary combination helps to deliver greater performance in radiology reporting at a fraction of the price of outsourced reporting.