X-ray analysis firm receives ISO 13485 and EU MDR certification

Radiobotics has been certified according to ISO 13485 and according to the new European Medical Device Regulations (MDR), and its product RBknee has been CE-marked under MDR as a class IIa medical device. 

This means that the healthtech company’s AI based solutions for radiology departments can continue to demonstrate quality and safety. Radiobotics being certified against the even higher European standards will eventually benefit both radiologists and patients.

To Radiobotics, the new certification is a recognition of the intense work with compliance, but also with developing AI-based medical devices in compliance with recognised standards and guidelines.

Martin Axelsen, CSO and co-founder of Radiobotics, said: “Patient safety is obviously of highest importance when developing medical devices. That is why the risk-based approach is central in everything we do during development of our products. Therefore, having gone through an MDR audit is a great achievement that we at Radiobotics are immensely proud of. This certification means a lot to us as it is of course proof to the healthcare industry that the way we build our AI based medical devices is of a very high quality.” 

The Danish-founded company used notified body TÜV SÜD and the certification means that Radiobotics can continue to commercialise their AI-based medical device software in the European market. 

Axelsen added: “We have had an efficient collaboration with consultants and TÜV SÜD in our efforts to pass the audit. Transparency in the area we’re operating in is very important and we have everything to win by being open and inviting the auditors to scrutinise every corner of our production and documentation. With our AI technology, we’re operating in a novel space, and we have a lot to prove in wanting to build strong relations with hospitals and radiology departments in particular. I think the compliance aspect of building medical devices is what keeps many entrepreneurs from venturing into this field but for Radiobotics it is important to contribute to a safe digitisation of the health industry.”