Qlife Holding AB reaches a key regulatory milestone with ISO 13485 certification for its at-home PHE diagnostic solution, strengthening the Egoo platform's path toward CE marking and future clinical partnerships.
Qlife has achieved ISO 13485 certification for its at-home PHE testing solution, a critical regulatory milestone that validates its quality management system. This certification serves as a foundational element for the company's Egoo Health platform, providing a scalable framework to accelerate future biomarker partnerships and streamline the path toward CE marking under EU IVDR.
The certification specifically covers Qlife's at-home blood testing solution for Phenylketonuria (PHE) and validates the company's quality management system for medical device design and manufacture.
It provides a regulatory and quality foundation that allows Qlife to build partnerships for individual biomarkers and creates a more efficient path from development to regulatory approval.
Qlife Holding AB has achieved ISO 13485 certification for its Egoo Health platform, specifically covering at-home Phenylketonuria (PHE) blood testing. This regulatory milestone validates the company's quality management system and provides a scalable framework for future biomarker partnerships and EU IVDR compliance.
It validates Qlife's quality management system for medical devices and establishes a regulatory foundation for their at-home diagnostic strategy, specifically for PHE testing.
It creates a scalable regulatory model that allows Qlife to pursue more efficient development and approval paths for future biomarker partnerships.