北京博标医疗设备标准化技术服务有限公司是中国标准化协会的团体会员单位,多年来从事代理医疗器械标准的编写、标准复核、产品检测、医疗器械生产许可证、医疗器械经营许可证、质量体系考核、临床试验(验证)、临床试验(验证)数据统计、医疗器械产品注册、体外诊断试剂(IVD)注册、质量管理体系、环境管理体系及职业健康安全管理体系等工作的专业咨询公司。公司内部有一批长期从事医疗及相关专业研究的工程师、咨询师,熟知医疗设备及医药等相关行业的法律法规,既能为企业提供专业技术的服务,出具第三方统计数据报告,又能为企业的产品在市场准入的审批环节上当好参谋,使企业少走弯路,节省时间,更合理的支配每一笔资金。
Beijing Bobiao Standardization Technology Service of Medical Device Co. Ltd.(Bobiao) is the member of China Association for Standardization (CAS). As a professional consulting firm, for many years, Bobiao has been engaged in the many fields, including the drafting and review of medical device standards, medical device testing, application of medical device manufacturing license and medical device business license, quality system assessment, clinical trials(validation), data statistics of clinical trials(validation), medical device registration, in vitro diagnostic(IVD) registration, quality management system, environmental management system, occupational health and safety management system and others. Bobiao has attracts a great number of professional engineers and consultants, who are long-term research in the medical and related industries. We are familiar with related laws and regulations in medical equipment registration and pharmaceutical industries. Therefore, we can not only provide professional and technical services and issue the third party statistic report, but also guide the registration of medical device products during the whole procedure. We can help your company to avoid detours and save time, making your every cent valued.
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