我们的核心团队成员均来自国内外顶级认证机构和知名医疗器械企业，拥有丰富的临床医疗器械产品成功上市经验。
Our core team consists of professionals from leading certification bodies and renowned medical device companies, both domestically and internationally. Their collective expertise encompasses a wealth of experience in successfully guiding clinical medical device products through the market launch process.
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创新器械申报，分类界定申请，型式检验辅导，注册/变更/延续辅导，生产许可辅导，同品种临床评价。
Innovative device applications, classification and definition consultations, type inspection guidance, registration/change/continuation advice, production license assistance, predicate device clinical evaluations.
Get Started技术文档服务、临床评价服务、型式检验服务、欧盟授权代表服务。
Technical Documentation Services, Clinical Evaluation Services, Type Inspection Services and EU Authorized Representative Services
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技术文档服务、临床评价服务、型式检验服务、欧盟授权代表服务。
Technical Documentation Services, Clinical Evaluation Services, Type Inspection Services and EU Authorized Representative Services
Get Started
技术文件服务，临床评价服务，型式检验服务，美国代理人。
Technical Documentation Services, Clinical Evaluation Services, Type Inspection Services, QSR 820 Quality System Services, and U.S. Agent Services
Get Started其它注册服务地区
东南亚
中东
俄罗斯
日本
韩国
巴西
加拿大
澳大利亚
印度
中国香港
中国澳门
中国台北
抗风疹病毒IgM
抗体检测试剂盒
早孕(HCG)
自测试剂盒
甲型肝炎病IgM抗体检测试剂盒
HBV PCR
试剂盒
肺炎支原体抗原
检测试剂盒
