Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification
Anumana , a leading AI-driven health technology company and portfolio company of nference , announced today that it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System.
- Anumana , a leading AI-driven health technology company and portfolio company of nference , announced today that it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System.
- This certification, the quality management standard for device manufacturers, indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical devices.
- Anumana received ISO 13485 certification following an independent third-party certification firm’s rigorous assessment of its Quality Management System.
- With this certification, Anumana strengthens its ability to provide software-as-a-medical device (SaMD) ECG-AI™ algorithms that consistently meet customer and regulatory requirements.