ADSS Builds a Global Quality and Regulatory Compliance Framework Aligned with International Standards
Quality assurance and regulatory compliance are fundamental pillars of sustainable development in the medical device industry. Recognizing this early on, ADSS began building its quality management framework with a long-term perspective, focusing on systematic capability rather than short-term certification outcomes.
The company obtained ISO 9001 certification in 2006, followed by ISO 13485 certification in 2007, formally establishing a quality management system aligned with medical device regulatory requirements. These systems provide structured guidance across product design, supplier management, manufacturing control, risk management, and post-market processes.
In 2009, ADSS achieved CE certification under TÜV Rheinland, enabling entry into the European market. This was followed by China’s first SFDA certification in 2011 and the company’s first FDA certification in 2016, demonstrating its growing capability to meet regulatory requirements across multiple jurisdictions.
By continuously aligning internal processes with evolving international standards, ADSS has transformed regulatory compliance into an internal operational capability. This systematic approach enhances product consistency, reduces compliance risks, and provides a stable foundation for long-term global market presence.
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