Intelligent Ultrasnd (LON:MED) ISO13485 certification for medical devices

Stuart Gall, Group CEO, commented: “With our first major AI licensing agreement signed last year and commercial discussions progressing for our second AI software product, this is an important milestone for the Group as we look to bring the first Intelligent Ultrasound AI products to market in 2020.”

Intelligent Ultrasound Group plc (AIM: MED) the ultrasound artificial intelligence (AI) software and simulation company, announces it has formally received ISO13485:2016 certification for its Quality Management System following review by the certification body LRQA. ISO13485:2016 is the internationally recognised quality standard to ensure the consistent design, development, production, installation and sale of medical devices that are safe for their intended purposes.

The Group’s Clinical AI division is in the process of bringing a range of AI-based image analysis software products to market and obtaining ISO13485:2016 certification is required to bring the Group’s real-time AI image guidance software products through regulatory approval.

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