Qlife has received ISO 13485 certification covering its at-home blood testing solution for PHE related to the Phenylketonuria condition, marking an important regulatory and quality milestone for the company and its Egoo Health platform.
The certification is particularly significant because its scope specifically encompasses at-home testing and PHE reflecting Qlife's strategy of developing quality-controlled diagnostic solutions that enable patients to perform sophisticated blood testing outside traditional laboratory and clinical settings.
To Qlife's knowledge, this represents a unique certification scope within at-home PHE testing.
ISO 13485 is the internationally recognized quality management standard for organizations involved in the design and manufacture of medical devices. For Qlife, the certification represents an important validation of the company's quality management system and the processes supporting the development of its PHE solution.
Thomas Warthoe, CEO of Qlife, comments:
"This is an important milestone for Qlife. The ISO certificate forms the regulatory and quality foundation for our at-home testing strategy. Going forward, we can build on this foundation as we enter partnerships around individual biomarkers, enabling a more efficient path from development to regulatory approval. We believe this creates a scalable regulatory model that significantly strengthens Egoo as a platform for future biomarker partnerships."
This important certification step towards CE marking under the EU IVDR, is fundamental for executing Qlife's broader regulatory strategy and establishes a quality and documentation framework that can support the company's continued development of at-home diagnostic solutions.
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