ISO 13485 Certified Medical Device PCBA Service
TECOO is an ISO 13485-certified, professional medical-grade printed circuit board assembly (PCBA) manufacturer and service provider. We specialize in providing high-reliability, full-process PCBA solutions, from prototyping to mass production, to global medical device manufacturers. Leveraging our rigorous quality management system, a clean production environment, and in-depth understanding of industry regulations, we ensure that every circuit board meets the highest medical application requirements for safety, effectiveness, and traceability.
- Fast Delievery
- Quality Assurance
- 24/7 Customer Service
Product Introduction
Our core strengths and services include:
1. ISO 13485-certified quality system: Our entire operational process adheres to the international medical device quality management system standard. This ensures comprehensive documentation, process control, and continuous improvement mechanisms at every stage, from material sourcing and production to final inspection, fully meeting global market registration and audit requirements.
2. Comprehensive regulatory compliance support: We are familiar with and strictly adhere to FDA 21 CFR Part 820, the EU Medical Device Regulation (MDR), and other international standards, such as ISO 14971 risk management and IEC 60601-1 safety requirements. We provide complete traceability reports, including component traceability, production batch records, and test data, providing solid support for your product's compliance registration.
3. End-to-End Solutions: TECOO offers one-stop services, including:
- DFM (Design for Manufacturability) Analysis: Intervention during the product design phase optimizes designs to improve reliability and manufacturability.
- Precision PCB Manufacturing and Assembly: Supports the manufacture of simple to complex boards, from single-layer to high-density interconnect (HDI) boards.
- Strict Testing and Validation: We offer a variety of testing solutions, including In-Circuit Test (ICT), Flying Probe Test, Functional Test (FCT), and Burn-in Test, to ensure flawless product performance.
- Case Assembly and System Integration: We provide further complete machine assembly services, saving customers supply chain management costs.
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