We are an AI-driven product R&D and development company — pairing 15 years of engineering expertise with a robust compliance infrastructure to build intelligent hardware for global medtech innovators.
DMT 是一家以 AI 驱动的产品研发与开发公司——15 年研发积累、六项有效国际认证，为全球医疗科技创新企业打造智能硬件。
ISO 13485TGA Q00557MDSAPIEC 60601-1IEC 62304ISO 10993
What We Build
我们的制造能力
End-to-end manufacturing. Concept to delivery.
从概念到装箱，一站式制造服务。
One point of contact from first sketch to final product — coordinating R&D, design, quality management, and a certified partner network for manufacturing and testing.
In-house engineering team designing custom vaporizer and medtech hardware from 3D CAD to prototype.
内部工程师团队，从三维 CAD 到原型，完成定制化雾化器及医疗硬件设计。
Tooling & Injection Molding
模具与注塑成型
Mold design managed in-house, with precision injection molding produced through vetted tooling partners — covering housings, cartridges, and structural components.
模具设计由内部团队主导，精密注塑通过经严格评审的合作伙伴设施生产，涵盖外壳、弹匣及结构件。
SMT Assembly
SMT 贴片组装
Access to certified partner SMT facilities for PCBA production, with AOI inspection and full traceability managed under our ISO 13485 QMS.
通过认证合作伙伴 SMT 设施完成 PCBA 生产，在我们 ISO 13485 质量管理体系下进行 AOI 检测与全程追溯管理。
Quality Testing & Validation
质量测试与验证
Incoming, in-process, and outgoing inspection per ISO 13485 QMS protocols. Full traceability and DHF documentation.
依照 ISO 13485 质量管理体系进行进货、在制、出货三段检验，完整设备历史文件（DHF）。
Firmware & BLE Integration
固件与蓝牙集成
Embedded firmware development, BLE 5.0 connectivity, and device-to-app communication stacks — delivered IEC 62304 compliant.
嵌入式固件开发、BLE 5.0 无线连接及设备与应用通信协议栈，符合 IEC 62304 标准。
Research & Development
研究与开发
15 years of engineering. Ready on day one.
15 年工程积累。从第一天起即可交付。
Proprietary knowledge in thermal systems, embedded software, and medical-grade materials — seamlessly integrated into our manufacturing process.
ISO 13485 QMS built and refined over years of medical-device production — not recently adopted for a client audit, but embedded in every process from NPI to production.
ISO 13485 质量管理体系历经多年医疗设备生产的建设与优化，从新产品导入到量产，每个环节均深度融合。
Thermal
Core Engineering Focus
核心工程方向
Thermal & Electrical Engineering
热能与电气工程
Our core engineering team specialises in closed-loop thermal control, PCBA design, and IEC 62304-compliant firmware — supported by partner facilities for SMT production and specialist lab work.
Internally developed IP across heating element design, precision delivery algorithms, and device-to-cloud communication architecture — licensable to exclusive OEM partners.
内部开发的加热元件设计、精密输送算法及设备云端通信架构相关 IP，可向独家 OEM 合作伙伴授权。
BLE
5.0 + On-Device AI
5.0 + 端侧 AI 推理
Connectivity & Intelligence Stack
连接与智能技术栈
Full BLE 5.0 device stack and companion app SDK — enabling seamless smart device functionality and real-time device connectivity.
完整 BLE 5.0 设备协议栈、配套应用 SDK 及端侧 AI 推理运行时，无需云端延迟即可实现智能设备功能。
ISO
10993 via Partner Labs
10993 生物相容性实验室
Materials Science
材料科学
Material selection and ISO 10993 test coordination via accredited partner laboratories — covering inhalation pathway components, seals, and contact surfaces for drug delivery applications.
内部材料筛选与 ISO 10993 测试协调，覆盖药物递送应用中的吸入通道组件、密封件及接触表面。
NPI
New Product Introduction Process
新产品导入流程
Structured Development Gateway
结构化开发评审门
Formal NPI process from feasibility through DVT to pilot run — with Design History File (DHF) and Device Master Record (DMR) built in parallel from day one.
General safety and essential performance requirements for medical electrical equipment.
医疗电气设备通用安全及基本性能要求。
IEC 62304
Medical Device Software Lifecycle
医疗器械软件生命周期
Rigorous software development lifecycle processes for embedded and application software in medical devices.
医疗器械嵌入式及应用软件的严格软件开发生命周期流程。
ISO 10993
Biocompatibility Testing
生物相容性测试
Biological evaluation of materials that contact the human body — mandatory for drug delivery and inhalation devices.
接触人体材料的生物学评价，药物递送及吸入设备强制要求。
Standards & Testing Performed
已执行的测试标准
Devices manufactured by DMT are tested against the following international standards for medical electrical equipment, inhalation devices and biocompatibility.
DMT 制造的设备均按照以下国际标准进行测试，涵盖医疗电气设备、吸入装置及生物相容性。
IEC 60601-1
General Safety & Essential Performance
通用安全与基本性能
Electrical shock, fire, mechanical and EMC safety of medical electrical equipment.
医用电气设备的电击、防火、机械及电磁兼容安全测试。
IEC 60601-1-2
Electromagnetic Compatibility (EMC)
电磁兼容性（EMC）
Immunity and emissions testing so devices operate reliably near other electronics.
抗扰度与发射测试，确保设备在其他电子设备旁可靠运行。
IEC 60601-1-6
Usability Engineering
可用性工程
Human-factors validation so the device is safe and intuitive to operate.
人因验证，确保设备操作安全、直观。
IEC 60601-1-11
Home Healthcare Safety
家庭医疗环境安全
Safety requirements for devices used by laypersons in home environments.
供非专业人士在家居环境使用设备的安全要求。
IEC 62304
Software Lifecycle Processes
软件生命周期过程
Structured development, verification and risk management for device firmware.
设备固件的结构化开发、验证与风险管理。
IEC 18562-1
Inhalation Pathway Biocompatibility
吸入通路生物相容性
Risk-based biocompatibility evaluation of the gas pathway in inhalation devices.
吸入装置气体通路的基于风险的生物相容性评估。
IEC 18562-2
Particulate Emissions
颗粒物排放
Measurement of particulate matter emitted from the device gas pathway.
设备气体通路颗粒物排放量测试。
IEC 18562-3
Volatile Organic Compound Emissions
挥发性有机化合物排放
Measurement of VOC emissions from the gas pathway into the aerosol.
气体通路向气溶胶中挥发性有机化合物（VOC）排放量测试。
IEC 18562-4
Leachables
可浸出物
Substances transferred from gas-pathway materials into the delivered aerosol.
气体通路材料向输出气溶胶中转移物质的测试。
ISO 10993-5
In Vitro Cytotoxicity
体外细胞毒性
Cell-culture testing of material biocompatibility.
材料生物相容性的细胞培养测试。
ISO 10993-10
Skin Sensitisation
皮肤致敏
Assessment of the potential to cause allergic skin reactions.
评估引发皮肤过敏反应的可能性。
ISO 10993-17
Toxicological Risk Assessment
毒理学风险评估
Allowable limits for leachable substances based on toxicological data.
基于毒理学数据确定可浸出物质的允许限值。
ISO 10993-18
Chemical Characterisation
材料化学表征
Identification and quantification of material chemical composition.
材料化学成分的鉴定与定量分析。
ISO 10993-23
Skin Irritation
皮肤刺激性
Assessment of the potential to cause skin irritation.
评估引发皮肤刺激的可能性。
"A compliance infrastructure refined over years of medical-device production — ready for our partners on day one.""我们的合规体系在多年医疗器械生产中不断完善，OEM 合作伙伴从第一天起就能直接使用。"
Technology Platform
技术平台
The future of medical devices is AI-driven.
医疗设备的未来， 由 AI 驱动。
DMT is an AI-driven product R&D and development company. We believe AI-enabled devices represent the next generation of medical technology — and we are building the hardware, firmware, and intelligence layer to lead that transition.
DMT 是一家以 AI 驱动的产品研发与开发公司。我们相信，AI 赋能设备代表着医疗技术的下一代方向——我们正在构建硬件、固件与智能算法层，引领这一变革。
Proven Hardware Platform成熟硬件平台
TCM-1 Benchmark Architecture
TCM-1 基准硬件架构
Our foundational TCM-1 hardware platform is a precision vapor eye wellness device — establishing DMT's standard in closed-loop thermal control, biocompatible contact surfaces, and ISO 13485 QMS production.
✓ Production Proven · ISO 13485 QMS
TCM-1 是我们的基准硬件平台，一款精密蒸汽眼部健康设备——奠定了 DMT 在闭环热控、生物相容性接触面以及 ISO 13485 质量体系量产上的高标准。
✓ 量产验证 · 符合 ISO 13485 标准
Thermal Engineering热工程技术
Precision Thermal Management
精密热能管理
Built into the TCM-1 core, our closed-loop thermal engine delivers consistent, repeatable temperature curves — critical for safe, precise vapor delivery in eye wellness applications.
DMT is actively pursuing NMPA Class II medical device certification for the TCM-1 vapor eye wellness device — enabling domestic market access for Chinese distribution partners.
A cloud-based platform enabling real-time device monitoring, usage analytics, and remote protocol management — designed for the China healthcare market. The software layer that transforms hardware into an intelligent, connected device ecosystem.
In Development · Next-Gen AI Roadmap研发中 · 下一代 AI 路线图
TCM-1 Intelligence Layer
TCM-1 智能算法层
Building on the proven TCM-1 hardware foundation, DMT is developing a proprietary software layer to bring real-time telemetry, session analytics, and cloud protocol management to future device iterations. This is DMT's bridge from precision manufacturer to AI-driven medtech platform.
在成熟的 TCM-1 硬件基础之上，DMT 正开发专有软件层，为未来设备迭代引入实时遥测、使用分析和云端方案管理——这是 DMT 从精密制造商迈向 AI 驱动医疗科技平台的战略跨越。
Architecture Design架构设计Phase 1 / 3
Evolutionary Focus
演进方向
Hardware → Smart SaaS Platform
硬件 → 智能 SaaS 平台
Connected medical device ecosystem
互联医疗设备生态
Deployment Target
部署目标
On-Device + Cloud Telemetry
端侧 + 云端遥测
IEC 62304 Lifecycle Standard
符合 IEC 62304 生命周期标准
Regulatory Alignment
法规对齐
NMPA SaMD · IEC 62304
NMPA 软件医疗器械 · IEC 62304
Software as a Medical Device pathway
软件医疗器械注册路径
Strategic Partners
战略合作伙伴
Built for the future of medtech.
为面向未来的合作伙伴而生。
We engage in exclusive manufacturing relationships, transforming our production capabilities into a strategic asset for our partners.
DMT 最具价值的合作关系都是独家的——我们的制造能力成为合作伙伴价值链中的战略资产。
Proposed Exclusive Manufacturing Partner拟独家制造合作伙伴
Ceres Vapor Tech Sdn Bhd
Ceres Vapor Tech Sdn Bhd
DMT is pursuing an exclusive manufacturing collaboration with Ceres Vapor Tech Sdn Bhd, an innovator in medical technology platforms. DMT provides end-to-end device manufacturing, firmware integration, and regulatory documentation support for Ceres's eye wellness product pipeline.
DMT 正与 Ceres Vapor Tech Sdn Bhd 推进独家制造合作——该公司是医疗技术平台领域的创新企业。DMT 为其眼部健康产品管线提供端到端设备制造、固件集成及法规文件支持。
Agreement Type
合作类型
Proposed Exclusive ODM Manufacturing
拟独家 ODM 制造
Full device lifecycle — design through logistics
完整设备生命周期，从设计到物流
Partner Jurisdiction
合作方注册地
Malaysia (Kuala Lumpur)
马来西亚（吉隆坡）
Target markets: MY · CN
目标市场：马来西亚 · 中国
Regulatory Scope
法规范围
NMPA Class II (pursuing) · MDSAP
NMPA 二类（推进中）· MDSAP
ISO 13485 DHF package included
含 ISO 13485 完整 DHF 文件包
Become a Partner
成为合作伙伴
DMT selectively takes on exclusive ODM mandates. Portfolio available under NDA. Contact us →
Portfolio and capabilities are available for qualified ODM/OEM partners under NDA. Please use the contact form below.可在保密协议框架下向合格 ODM/OEM 合作伙伴提供产品组合与能力介绍。请使用下方联系表单。
How We Work
合作流程
Concept to container. In five steps.
从概念到集装箱，五步完成。
A documented, heavily validated manufacturing process designed for international brands entering regulated markets.
经过验证、文件完备的制造流程，专为进入监管市场的国际品牌设计。
1
Concept & NDA
概念与保密协议
Feasibility review, regulatory pathway mapping, and NDA execution before any IP is shared.
Design validation, regulatory testing, biocompatibility, and client approval sign-off.
设计验证、法规测试、生物相容性检验及客户审批确认。
4
Mass Production
量产
Coordinated SMT assembly via certified partner facilities, firmware flashing, QMS-controlled in-process testing, and final OQC.
全线 SMT 组装、固件烧录、QMS 管控的在线测试及出货质量管控（OQC）。
5
Logistics & Docs
物流与文件
Export packing, freight coordination, CoC/CoA documents, and full regulatory submission package.
出口包装、货运协调、CoC/CoA 文件及完整法规申报资料包。
Our Facility
工厂设施
Dongguan. Built for quality.
东莞。为品质而生。
Our Dongguan facility houses core R&D, engineering, and quality management — working with a trusted network of certified partner facilities for tooling, SMT assembly, laboratory testing, and specialist certifications.
When you use the enquiry form on this website, we collect your name, company, business email, target market, and the details you include in your message.
当您使用本网站的咨询表单时，我们会收集您的姓名、公司、商务邮箱、目标市场以及您在留言中填写的内容。
How We Use It
信息用途
We use this information to respond to your enquiry, prepare feasibility and timeline estimates, and manage business discussions — including under a non-disclosure agreement when requested. We do not sell, rent, or trade your information.
Your information is shared only with DMT personnel involved in responding to your enquiry, and with partner facilities only where necessary to answer it.
您的信息仅与负责回复您咨询的 DMT 内部人员共享，仅在必要时与合作伙伴工厂共享以解答您的咨询。
Cookies
Cookie
This website does not set tracking cookies. If analytics are added to the production site, this policy will be updated accordingly.
本网站不设置追踪型 Cookie。如正式网站增加数据分析功能，本政策将相应更新。
Retention & Your Rights
数据保留与您的权利
We keep enquiry records until the relevant project concludes, or until you ask us to delete them. You may request access, correction, or deletion of your data at any time by emailing ken@dmedicatech.com.
This website describes the manufacturing capabilities of Dongguan Medica Technology Co., Ltd ("DMT"). Content is provided for general information only and does not constitute medical, regulatory, or legal advice.
Descriptions of products and capabilities are illustrative. Nothing on this site is a claim of therapeutic efficacy, treatment, or clinical outcome.
产品及能力描述仅作示意说明。本网站不构成任何疗效、治疗或临床结果的声明。
3. Intellectual Property
3. 知识产权
All content, graphics, logos, and marks on this site are owned by DMT or its licensors. Reproduction, distribution, or commercial use without prior written permission is prohibited.
Please do not send confidential or proprietary information through the contact form. Confidential discussions proceed only under a mutually executed non-disclosure agreement.
请勿通过联系表单发送保密或专有信息。保密讨论仅在双方签署保密协议后进行。
5. Limitation of Liability
5. 责任限制
DMT makes no warranties about the completeness or accuracy of site content and is not liable for decisions made in reliance on it. The site may be updated or changed without notice.
