杭州宇翼科技有限公司

杭州宇翼科技有限公司

Hangzhou Yuyi Technology Co., Ltd.

国内外医疗器械注册临床试验平台

Domestic and international medical device registration clinical trial platforms

公司资深团队熟悉中国NMPA、欧盟MDR/IVDR、美国FDA510K/PMA等多个国家和地区的医疗器械法规，具备在全球范围内进行医疗产品注册和认证的能力。同时发挥丰富的临床试验和准入注册经验，协助客户加速产品上市和全球推广提供优质服务。

The senior team of the company is familiar with medical device regulations in multiple countries and regions, including China's NMPA, EU's MDR/IVDR, and the United States' FDA 510K/PMA, and has the ability to register and certify medical products globally. At the same time, leveraging our rich experience in clinical trials and admission registration, we assist clients in accelerating product launch and providing high-quality services for global promotion.

全球医疗器械注册

Global Medical Device Registration

1. NMPA

2. MDR/IVDR

3. 510K/PMA

4. TFDA

5. Clinical Trials

全球委托生产加工

Global commissioned production and processing

1. 自建工厂  Self built factory

2. 质量体系建立  Establishment of Quality System

3. 委托生产（认证样品）  Commissioned production (certified samples)

4. 大量生产委托（鸿海.华硕.第三方）  Large scale production outsourcing (Foxconn, Asus, third-party)

1. 中国NMPA临床试验  Clinical trials of NMPA in China

2. FDA.PMA临床试验  FDA. PMA clinical trial

3. MDR临床试验  MDR clinical trials

4. 多国多中心临床试验  Multi country and multi center clinical trials

5. 临床评价 Clinical Evaluation

1. 医工研发对接  Medical engineering research and development docking

2. 项目风险管理  Project risk management

3. 全球销售对接  Global sales docking