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Helmann Medical is a professional company specializing in the implementation of surgical shadowless lamps, hanging towers and operating room overall solutions. We have our own design and development center, technical support department, production center. The theme of quality runs through the entire life cycle of HELMANN products - from product development to marketing. We are in Nanjing Jiangbei New District, national science and technology industrial Park special customer experience center, with a total area of nearly 1500 square meters. At present, there are branches and maintenance centers in Beijing, Nanjing, Xi 'an, Hefei and Fujian. 400-888-9094 24-hour free repair hotline, quickly respond to your after-sales needs. We are convinced that we can provide the best products, the most reasonable price and the best after-sales service for hospital equipment!

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资讯列表

医疗器械从研发到上市的九大历程

近年来,“医疗器械注册人制度”全面实施,使得“两证”得以捆绑,大幅度降低了厂房、设备等投资成本。 于是,新年伊始,很多企业蓄势待发,准备扩大规模;还有很多新进行业的企业,准备浩浩荡荡地大干一场。

2023.05.05

快速对比之——医疗器械之GMP

新版规范全文十五章,131条,强调应将风险管理贯穿产品实现全过程,重视数据管理与溯源,建立质量保证系统并保证质量管理体系有效运行,既要求产品质量,又引导促进产业高质量发展;新增质量保证与风险管理、数据管理、电子记录、验证与确认、委托生产、外协加工,对困扰业界的术语第一次给予明确解释,内容丰富、全面,与14版相比,质量管理要求又上一个新台阶,对企业对监管人员都是新挑战。

2023.05.08

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