Certificate
PRECLINICAL STUDY CENTER FOR INNOVATIVE MEDICAL DEVICE
CERTIFICATE
CNAS-CL06:2018(GB/ T27416-2014)
It meets the requirements of CNAS-CL06:2018 Guidelines for Accreditation of Competence and Quality of Laboratory Animal Breeding and Use Institutions (GB/T 27416:2014 General Requirements for Quality and Competence of Laboratory Animal Institutions). It has the capacity to use and/or utilise laboratory animals in a scientific, humane and ethical manner.
OECD GLP
From 14 to 15 October, GoldenWing (Suzhou) Medical Technology Co., Ltd, underwent a rigorous audit by GLP inspectors from the Organisation for Economic Co-operation and Development (OECD). After a comprehensive and meticulous inspection by the expert panel, GoldenWing Medical demonstrated exceptional levels in key areas such as laboratory management, animal testing, personnel management, experimental facilities, quality assurance system and documentation, and successfully passed the OECD GLP on-site inspection!
US FDA GLP
Following a successful on-site review by the US client in accordance with the Code of Federal Regulations 21 CFR Part 58 GLP, the test has now been carried out. As a result, the business is now formally open to the world to undertake the business of large-animal testing in accordance with the GLP standard, officially undertake preclinical large animal testing for US FDA PMA, 510K declaration.
Licence for Use of Laboratory Animals
License for Use of Laboratory Animals Certificate No. SYXK (SU) 2023-0002 Unit Name: GoldenWing (Suzhou) Medical Technology Co., Ltd. Legal Representative: Xufeng WEI Facility Address: No. 200 Xingpu Road, Shengpu Street, Suzhou Industrial Park Scope of Application: General environment (general level: rabbits, dogs, monkeys, cats, pigs, building 20, 4706 m²)
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