January 2025: Horien biotech officially listed on the Emerging Stock Market (stock code: 7814).
July 2025: Horien biotech's quality management system passed a third-party certification audit and obtained the ISO 13485 certificate issued by DNV.
Introduction to ISO 13485 Medical Device Quality Management System
ISO 13485 is the latest international standard for quality management systems in the medical device industry.
This standard has been adopted by medical device regulatory authorities worldwide, including the United States and the European Union, or reconciled with their quality system regulations.
Its provisions and requirements have become the benchmark for GMP, MDSAP, and EU medical device regulations in various countries in standardizing medical device quality systems.
Ensuring that a medical device manufacturer's quality management system continues to comply with ISO 13485 requirements through important activities such as management reviews and internal audits is crucial for improving the compliance of the quality system with regulatory requirements.
