Medical diagnostics company Rhythm Biosciences (ASX:RHY) has announced its Quality Management System (QMS) has just been certified as compliant with the International Organization for Standardisation (ISO) EN 13485:2016 standard.
The company said the assessment was conducted by British Standards Institution (BSI) Group, the business standards company and market leading UK Notified Body.
EN ISO 13485:2016 is the internationally recognised quality standard that is designed to ensure the consistent design and development, production, storage and distribution of medical devices that are safe for their intended purposes. It is recognised by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry.
The company said it is the first step in achieving compliance with European and Australian regulatory requirements and a major milestone in its pathway to market.
Certification with this standard enables Rhythm to be classified as a manufacturer of In Vitro Diagnostics and Medical Devices for its own and in-licensed products for worldwide registration and sale.
“ISO 13485 certification represents another step on Rhythm Biosciences’ path to developing and commercialising its ColoSTAT screening and diagnostic test for the detection of colorectal cancer,” said Rhythm Biosciences CEO, Glenn Gilbert.