Quality Policy Statement

Lin-Zhi International, Inc.’s pledge to our customers is to deliver high quality in vitro diagnostic medical devices that meet or exceed their expectations. We strive to provide qualified technical support and attentive, professional customer service. There are several business aspects that play a role into the company including the manufacturing process, products, quality control, and customer interactions. All those aspects are required to be first rate, supplemented with thorough, traceable documentation, and produced under good manufacturing processes (GMP), ISO 13485:2003 (International Organization for Standardization for medical device quality management system requirements), 21 CFR 820 (quality system regulation for medical devices), the European Union’s In Vitro Diagnostic Directive IVDD 98/79/EC, and Canadian Medical Devices Conformity Assessment System (CMDCAS). Since the medical device industry is well regulated, the safety and efficacy of our Quality Management System (QMS) and devices are high priority.  In conclusion, as part our commitment to excellence, we seek to continually improve our QMS and products.

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