德握医疗科技（北京）有限公司Durwood Medical · Beijing
22年中国经验｜中英双语沟通｜熟悉工厂协作与出口流程
22 years navigating the China market. Native Mandarin. Deep factory relationships and export process expertise.
重交付，重合规，重沟通，重长期合作
Delivery. Compliance. Communication. Long-term partnership.
关于我们About
德握医疗科技是一家专注于不锈钢非动力手术器械领域的跨境采购与市场协调机构，根植北京，服务于希望进入或深耕中国市场的国际制造商及中国采购方。
Durwood Medical is a Beijing-based cross-border sourcing and market coordination partner specializing in stainless steel, non-powered surgical instruments. We serve international manufacturers seeking structured, compliant access to the China market.
市场准入
Market Access
协助制造商完成中国市场注册、合规审查及渠道开发
NMPA registration, compliance review, and China channel development
品质协调
Quality Coordination
在生产、检验与交付各环节执行系统化质控流程
Systematic QC management across production, inspection, and delivery
跨境执行
Cross-border Execution
协调出口文件、供应链物流及中英双语沟通
Export documentation, logistics, and bilingual communication as standard
下了订单就会交货。
文件齐全，口碑可查，不打折扣。
"Orders are fulfilled. Documentation is complete. Reputation is verifiable. No exceptions."
— Patrick Yu, General Manager合作方向Capabilities
覆盖高端精品、量产稳供与一次性器械，满足不同层级的市场需求
From premium reusable instruments to high-volume supply and single-use devices — matched to the right China market approach.
覆盖普外、骨科、耳鼻喉、眼科、口腔等科室
General surgery · Orthopedics · ENT · Ophthalmology · Oral
适合稳定采购与长期供货需求
For distributors requiring consistent, long-cycle procurement
符合FDA / ISO / NMPA相关要求
FDA · ISO 13485 · NMPA compliant
品质标准Quality & Compliance
我们在供应链的每个关键节点实施系统化质控，覆盖原材料验收、生产过程审查、出货前检验，以及完整的可追溯文件管理。合规不是选项，而是基本条件。
We implement structured quality controls at every critical node — raw material acceptance, in-process review, pre-shipment inspection, and full traceability documentation. Compliance is not optional. It is the baseline.
ISO 13485
医疗器械质量管理体系
QMS for medical devices
FDA 510(k)
美国市场注册路径
US market clearance
NMPA
国家药品监督管理局
China regulatory body
CE MDR
欧盟医疗器械法规
EU Medical Device Regulation
原材料可溯源
Material Traceability
所有原材料均附带材质证明，来源可追溯至轧钢厂
All raw materials carry mill certificates traceable to source
过程检验留档
In-Process Documentation
每批次生产均有完整检验记录，可供审计查阅
Each batch carries complete inspection records, audit-ready
出口文件完备
Export Documentation
包括商业发票、装箱单、原产地证书及法规所需报告
Commercial invoices, packing lists, COO, all regulatory reports
工厂审计支持
Factory Audit Support
合作工厂接受第三方审计，欢迎买方安排实地考察
Partner factories support third-party audits and buyer site visits
合作伙伴Partner With Us
我们不追求数量，只选择适合长期合作的伙伴。无论您是希望进入中国市场的国际制造商，还是寻求稳定、合规货源的国内采购方，我们的标准始终如一：系统完善，文件齐全，承诺可靠。
We are selective by design. We work with international manufacturers who are serious about the China market — with the systems, documentation, and long-term commitment this market demands. If that describes you, we should talk.
您拥有成熟的生产能力与认证体系，希望打开中国市场，但缺乏本地资源与语言优势。我们作为您在华的独家分销与协调伙伴，负责从注册到交付的全程对接。
You have production capability and certifications. You need a China-side partner who understands both the regulatory environment and buyer psychology. We handle full coordination — from NMPA registration to end-buyer relationships.
您需要稳定、合规、可追溯的国际品质器械货源，并要求完整的中文沟通与文件支持。我们提供直接对接工厂的采购渠道，省去中间环节，确保全程透明。
You require stable, compliant, internationally-sourced instruments with full Chinese-language documentation support. We provide direct factory access with transparent supply chain management and complete bilingual documentation.
联系我们Contact
请告知您的采购需求或合作意向，我们将在两个工作日内回复。也可直接发送邮件至 info@durwoodmedical.com
Tell us about your sourcing requirements or partnership interest. We respond within two business days. You can also email us directly at info@durwoodmedical.com
所有询盘保密处理。All inquiries handled in strict confidence.
感谢您的留言！我们将在两个工作日内与您联系。
Thank you. We will be in touch within two business days.