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Topcon Healthcare’s Harmony Referral System Achieves MDR Class IIa Certification

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Topcon Healthcare is pleased to announce that the Harmony Referral System (version 3) has been certified as a Class IIa medical device under the European Union Medical Device Regulation (EU MDR) 2017/745. 

This certification affirms that Harmony meets the stringent EU regulatory framework for medical-grade software, including safety, performance, clinical evaluation, and quality management. The MDR Class IIa designation confirms Harmony’s role as a clinical data management platform designed to aid in diagnostic processes and clinical decision-making. 

Harmony is a cloud-based system that enables eye care providers to connect and manage data from all diagnostic instruments—regardless of manufacturer—within a single platform. Its seamless integration capabilities enhance clinical workflows, facilitate collaboration, and help deliver better patient outcomes. 

The MDR certification follows a comprehensive conformity assessment by a notified body and underscores Topcon Healthcare’s commitment to innovation excellence and regulatory compliance. 

 

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Harmony

Learn more about Harmony
Harmony from Topcon Healthcare is a web-based data management platform that connects ophthalmic instruments and professionals to enhance clinical workflows. It integrates with all instruments, regardless of brand, for easy comparison and analysis of patient data on a single screen. Harmony streamlines processes with EMR integration, customisable e-referral workflows, and secure data exchange. It also supports AI-powered clinical decision tools for automatic image analysis, improving efficiency and accuracy in eye care.