Quality System

Wanhai Medical Quality Management

We implement and maintain the highest industry standards in the process of design, development, and manufacturing. Our quality management system complies with global medical device regulations (including 21 CFR 820) and has passed ISO 13485:2016 and CE certification. For Wanhai Medical, complying with these regulations and standards means not only implementing the quality system but also ensuring that quality-oriented thinking is a core component of our corporate philosophy. As a part of the development service, Wanhai Medical thoroughly recorded each stage of the process in comprehensive design history documents. These documents cover all documents required for submitting regulatory declarations and can be provided directly in CTD or STED format. In Wanhai Medical, every development activity is accompanied by the most advanced risk management process. We use best practices to ensure that risks are minimized through a systematic approach, including all steps and aspects of equipment handling, design, and manufacturing. In order to meet the business needs of customers, we manufacture hundreds of millions of parts, components, sub-assemblies, and finished products every year, which brings many challenges to our quality management. Every year, our quality system is systematically challenged by many audits by customers and regulators.