Empowering Next-Gen
MedTech Innovation
赋能下一代
医疗科技创新

Medsensoric is your trusted partner. From high-precision sensor development (ECG/EMG) to global medical device registration and risk management, we provide end-to-end customized solutions. Medsensoric 是您值得信赖的合作伙伴。从高精度传感器开发(ECG/EMG)到全球医疗器械注册及风险管理,我们提供全方位的端到端定制化解决方案。

[医疗技术开发场景]

Our Core Expertise我们的核心专业领域

Custom Product R&D医疗产品定制开发

Specializing in high-precision physiological signal acquisition (ECG, EMG) and smart sensor integration to meet rigorous clinical standards. 专注高精度生理信号采集,如 ECG(心电)、EMG(肌电)及各类智能传感器集成,满足临床严苛要求。

  • Hardware & Firmware Design硬件电路/固件设计
  • Low Power Wireless Transmission低功耗无线传输
  • Prototyping & Testing原型制作与测试

Registration Services医疗注册服务

End-to-end NMPA, CE, and FDA registration support to accelerate market entry and shorten time-to-market for your devices. 覆盖 NMPA、CE 及 FDA 注册全流程,协助客户快速获取市场准入,缩短产品上市周期。

  • Technical Documentation (TD)技术文档(TD)编写
  • Testing & Rectification Agency检测代理与整改
  • Clinical Evaluation Report (CER)临床评价报告

Risk Management风险管理服务

ISO 14971-based risk analysis and control throughout the product lifecycle to ensure patient and user safety. 基于 ISO 14971 标准,提供贯穿产品全生命周期的风险分析与控制,确保患者与用户安全。

  • Risk Analysis Report风险分析报告
  • Safety Testing Design安全性试验设计
  • Post-market Surveillance上市后监督体系
[心电图ECG开发案例]
Technical Advantages技术优势

Precision Sensor Integration精密的传感器集成技术

"We are not just developers; we are the gatekeepers of medical compliance." “我们不仅是开发者,更是医疗行业的合规守门人。”

ECG & Bio-signal ProcessingECG & 生物电信号处理

High CMRR design to accurately extract weak physiological signals while resisting interference. 高共模抑制比设计,精准提取微弱生理信号,抵抗环境干扰。

Embedded Algorithm Development嵌入式算法开发

Real-time QRS detection, heart rate variability (HRV) analysis, and edge computing capabilities. 实时 QRS 波群检测、心率变异性分析等边缘计算能力。

ISO 13485 Compliant WorkflowISO 13485 开发流程

Strict design controls with full traceability from requirements to validation & verification. 严格的设计控制规范,从任务书到验证确认的全程追溯。

Ready to Start Your MedTech Project? 准备好开始您的医疗项目了吗?

Whether you need product design from scratch or guidance through complex regulatory hurdles, the Medsensoric expert team is here to help. 无论您是需要从零开始的产品设计,还是寻求复杂注册法规的指导,Medsensoric 专家团队都将竭诚为您服务。

Contact us via email or the form for project inquiries. 请通过邮件或右侧表单与我们联系进行项目咨询。