Qserve | Your MedTech Partner for Regulatory, Quality Affairs, and Clinical Trials

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五月 13, 2025

How do you interpret laws and regulations in your product development to comply with the MDR?

The European Medical Device Regulation(MDR 2017/745) represents one of the most significant regulatory overhauls in the medical device industry. Find out more in our blog!

Qserve是欧盟境内100%专注于医疗器械和体外诊断领域最大的咨询公司。敬请观看我司视频。

欧洲

我们对于欧盟医疗器械（EU-MDR）的了解，确保我们能以有效的监管策略提供培训和支持

中国

我们可以提供广泛的定制服务，帮助您进入中国市场

美国

我们帮助上百医疗器械制造商提交FDA申请。Qserve可以作为美国代理人和官方联络人。

All regions

为何选择Qserve作为您的法规顾问？

我们清楚地知道需要做哪些准备来达成并保持合规
强大的国际团队，拥有技术、法规和临床能力
前欧盟公告机构、美国FDA和中国药监工作人员
全套的医疗器械CRO服务
我们的团队拥有各个级别的咨询师，从初级到首席。基于您的项目要求形成高性价比团队
我们依据完成的任务收费，没有隐性消费
我们培训并留下成果，打上合规烙印
一个联络窗口，接触所有团队专家
在中国、欧洲和美国设有分支机构

我们的方式

"我们的使命是用切实可行的方式支持医疗器械制造商，将现有法规转换成可理解的要求"

Jan van Lochem , CEO

新闻

博客

五月 13, 2025

How do you interpret laws and regulations in your product development to comply with the MDR?

The European Medical Device Regulation(MDR 2017/745) represents one of the most significant regulatory overhauls in the medical device industry. Find out more in our blog!

博客

五月 09, 2025

New UDI-DI Registration Requirements in Colombia: What Medical Device and IVD Manufacturers Need to Know

In an effort to align with global best practices and strengthen the traceability and safety of Medical Devices (MD) and In Vitro Diagnostic (IVD) Devices, Colombia has introduced new requirements. Read about it in our blog.

All articles

活动

六月 05, 2025 - 六月 05, 2025 /

Meet and Greet Mindy McCann at the RAPS DC/Baltimore Area Chapter

活动

六月 16, 2025 - 六月 20, 2025 /

Meet and Greet Bianca Lutters at MedTech Summit by informa connect

All events

Medical Device consultancy

IVD Consultancy

Market Access

Medical Device CRO

Webinars & Events

Knowledge Center

您的法规、质量和临床试验医疗技术合作伙伴

Qserve是欧盟境内100%专注于医疗器械和体外诊断领域最大的咨询公司。敬请观看我司视频。

欧洲

中国

美国

为何选择Qserve作为您的法规顾问？

我们的方式

新闻

How do you interpret laws and regulations in your product development to comply with the MDR?

New UDI-DI Registration Requirements in Colombia: What Medical Device and IVD Manufacturers Need to Know

活动

Meet and Greet Mindy McCann at the RAPS DC/Baltimore Area Chapter

Meet and Greet Bianca Lutters at MedTech Summit by informa connect