Tekcapital #TEK investee company Belluscura #BELL receives certification to major ISO standard

Belluscura, a leading medical device developer focused on lightweight and portable oxygen enrichment technology, is pleased toannounce today that it has been certified as compliant with ISO standards for Quality Management (ISO 13485:2016), allowing 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 one of the world’s leading standards-settings bodies. 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 organization 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 (CE mark), UK (CA mark), China and the rest of the world.

Robert Rauker, CEO of Belluscura plc, 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.”  

ENDS

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About Belluscura plc   (   www.belluscura.com   )

Belluscura is a UK medical device company focused on developing high performing, lightweight and portable oxygen enrichment technology used in a broad range of industries and therapies. Our innovative oxygen technologies are designed with a global purpose: to create improved health, mobility and economic outcomes for patients, healthcare providers and insurance organisations.

Glossary

X-PLOR® is a lightweight portable oxygen concentrator with user replaceable oxygen enrichment cartridges and direct-charge batteries. Weighing only 3.75 lbs, its Airgonomic^TM Design ensures user-friendly experience and maximum comfort. It has multiple Pulse Flow Settings including X-PLORATION^TM Mode (750mL for 10 mins). 

DISCOV-R™ will deliver 2000mL of continuous flow oxygen and have 8 Pulse Flow Settings. Weighing only 6.5 lbs, it will be the first a mbulatory 2L portable oxygen concentrator, producing more oxygen per pound than others in its class.