Rhythm Biosciences Ltd (ASX: $RHY) has confirmed its compliance with ISO 13485:2016, the International Standard for In-Vitro Diagnostics and Medical Devices, for the sixth consecutive year. The certification, conducted by the British Standards Institution (BSI), ensures the consistent design, development, manufacture, and sale of medical devices that are safe for their intended purposes.
Rhythm Quality Manager, Donald Joseph, stated, 'Rhythm continues to maintain a Quality Management System in line with ISO13485:2016, allowing us to prepare for the launch of ColoSTAT® into the relevant markets internationally.'
Rhythm Biosciences Ltd (ASX: $RHY) has retained its ISO 13485:2016 certification for the sixth consecutive year, demonstrating its commitment to quality management in the development and sale of medical devices. The ISO certification is crucial for supporting regulatory approval processes, market confidence, and operational credibility. Rhythm's ColoSTAT® Test-Kit, based on research from Australia's CSIRO, holds the potential to play a key role in reducing the mortality rate and healthcare costs associated with colorectal cancer, aligning with the company's goal of improving patient outcomes through early cancer detection.