医疗技术进入欧洲市场

Your European market entry strategy depends on your starting point. Regulatory expectations, clinical evidence requirements, and typical EU entry risks vary significantly between US and Chinese MedTech manufacturers. We tailor your EU entry strategy based on your regulatory background, clinical maturity, and business objectives.

我们解决的关键挑战

从FDA或NMPA到MDR/IVDR

了解关键的欧盟法规差异，转化您的临床证据，适配现有数据，并规划与公告机构的路径。

差距分析和文档

识别差距，优化文档，在专家法规指导下缩短上市时间。

可持续的合规

通过生命周期管理和上市后监督支持实现可持续合规。

您值得信赖的医疗器械和IVD欧盟市场进入合作伙伴。

与我们合作

法规路径

在专家指导下导航MDR和IVDR。

• 产品分类和法规策略
• 技术文档和公告机构准备
• 差距分析和整改规划

临床证据

制定正确的临床证据策略。

• 临床评价报告准备
• PMCF研究设计和执行
• 文献综述和等效性评估

QMS对齐

使您的质量体系符合欧盟期望。

• ISO 13485差距评估和实施
• 设计控制和风险管理对齐
• 满足欧盟要求的供应商资质审核

上市后合规

在整个生命周期中保持合规。

• 上市后监督规划
• 警戒报告和PSUR准备
• 定期安全更新管理

Multi-Country Clinical Trial for CE-Mark Success in the UK

Navigating complex UK regulations to deliver a seamless, multi-country clinical trial for coronary artery disease

• Challenge: Client needed critical data for their CE-mark application through a multi-country clinical trial, facing the complexities of navigating UK regulatory requirements, which many companies avoid due to its challenges.
• Approach: Full support for the LiquID Safety study from start-up to closure. Study monitoring, regulatory submissions, and project oversight. Streamlined UK submission processes and leveraged top-tier UK investigational sites for the study.
• Result: The study enrolled 86 subjects across Belgium, UK, and Scotland, and was completed successfully in Q1 2024. Demonstrated the value of UK investigational sites in a First-in-Human trial for coronary artery disease. The positive outcome led to further collaborations, with the client recommending our services to other clients.

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Empowering a First-In-Human Clinical Trial Success

Expert guidance and seamless project management for breakthrough medical innovations in heart failure treatment

• Challenge: Client faced difficulties navigating the complex EU regulatory landscape to set up and manage their first multi-country clinical trial for the V-LAP System, without prior EU trial management experience.
• Approach: Initially covered the UK, expanding to Spain and offering consultancy and project management support. Assigned experienced CRAs for trial monitoring, regulatory submissions, and document creation. Provided comprehensive advisory services to ensure compliance with EU standards.
• Result: 30 subjects enrolled across five countries for the ongoing First-in-Human study. Successful start-up phase completion and knowledge transfer enabled Vectorious to manage many trial aspects independently. Strong collaboration led to future project opportunities through industry referrals.

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