Good Biotech Corp. has developed an extensive internal Quality Assurance program and our facilities are EN ISO 9001:2000、 EN ISO 13485:2003 and IVD GMP Certified. In order to satisfy our worldwide quality conscious customers especially in North America, European and Japan, our diagnostic products are CE Marked、 FDA (510)k Cleared、IVD GMP approval. In meeting the requirements of these harmonized standards, the company demonstrated that it has a conforming Quality System in place, with processes that are consistently executed in daily operations. We have commitment to our international markets through the global harmonization of regulatory compliance requirement and all the employees of Good Biotech Corp. are fully committed to the Company Procedures and Policies.
Certifications
EN ISO 9001:2000 Quality Management System
EN ISO 13485:2003 a quality management system for medical devices for Design, Development, Manufacturing and Sales of Immunoassay Kits and Polyclonal Antibodies from Duck and Purified Protein
FDA 510(k) clearance
IVD GMP
