Belluscura certified as ISO 13485 compliant – Med-Tech Innovation

This allows for design, development, manufacture and distribution of its portable oxygen concentrators (POC) following an extensive audit process undertaken by leading global assurance provider SGS.

The Group’s manufacturing facilities in both Texas and China achieved ISO 13485 certification ahead of schedule, following a complete review of our quality systems and processes, including the newly insourced manufacturing facility.

The International Organization for Standardization (“ISO”) is a world leading standards-settings body. The Organization develops standards to ensure the quality, safety and efficiency of products, services, and systems; those standards are recognised globally as the benchmark for operational excellence among leading manufacturing companies.

The individual standards to which Belluscura is now certified are core to the company’s business. ISO 13485:2016 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. The certification, therefore, enables the Group to apply to distribute the X-PLOR and DISCOV-R in Europe, the UK, China and the rest of the world.

Robert Rauker, CEO of Belluscura, said: “This is a hugely significant step for the Group, as ISO 13485 certification will enable the company to begin the process to start distributing its products globally. Our existing market in the US represents approximately 45% of the Portable Oxygen Concentrator market, so this certification more than doubles the available market opportunity for the Group.

“The certification shows the dedication of our team to not only developing a quality product, but to being a leading manufacturer of portable oxygen concentrators. Compliance with this standard will enable Belluscura’s commercial development by proving to new customers that the company adheres to the highest standards of quality management excellence.

“It will, therefore, contribute to our growth as we expand production of our X-PLOR device and the Nomad Biometric App, as well as the DISCOV-R, which we expect to launch in Q1 2023 as the world’s first ambulatory dual flow portable oxygen concentrator.”