Certified for Medical Excellence: Global Compliance, Lifesaving Reliability
We have obtained ISO 13485 medical system certification and comply with FDA 21 CFR Part 820 standards, focusing on the field of high – reliability medical electronics. By strictly following international standards, we aim to provide you with the safest and most reliable FDA – approved PCBA for healthcare.
Full Traceability
Raw material batch records are stored for more than 15 years, ensuring that every production link can be traced, providing a solid guarantee for product quality. Whenever and wherever, you can accurately trace the origin of the product and have peace of mind.
Cleanroom Production
Class 8 (ISO 14644 – 1 environment) cleanroom dedicated to implantable devices. The production environment is strictly controlled to effectively reduce dust particles and microbial contamination, ensuring the high purity and stability of products and meeting the strict requirements of implantable medical devices.
Biocompatibility Testing
The materials of skin – contact devices comply with ISO 10993 standards, ensuring that no adverse reactions occur when in contact with human tissues and body fluids, and safeguarding the health and safety of patients.
From Diagnosis to Treatment
Our medical – grade PCBA solutions are widely applied to various medical devices, covering the entire medical treatment process from diagnosis to treatment and fully meeting the needs of the medical industry.
Why Trust China Dragon? Engineering for Healthcare
- 10+ Years in Medical PCBA
- Prototype to Mass Production
- Cost - Effective
We have served over 120 clients in 15 countries around the world, accumulating rich industry experience and professional knowledge. We have a deep understanding of the needs of different regions and types of medical devices and can provide you with customized solutions to meet your diverse needs.
Minimum order quantity (MOQ) is 1 pieces, with a fast turnaround of 2 days. Whether it is small – batch prototyping in the product R & D stage or large – scale production requirements, we can respond quickly to help you shorten the product launch cycle and seize market opportunities.
Our product quality is comparable to that of EU/US suppliers, but the cost is 20% lower. On the premise of ensuring product quality, through optimizing the production process and supply chain management, we provide you with cost – effective solutions to help you reduce costs and improve market competitiveness.
Technical Edge: Miniaturization, Low Power Consumption, Long Life
Our medical – grade PCB assembly has significant technical advantages, providing strong support for the innovative development of medical devices.
Start Your Project
We Simplify Medical Compliance，Optimize Your Medical – grade PCB Assembly Design
Obtain a manufacturability report within 24 hours. Our professional team will provide a comprehensive evaluation and optimization suggestions for your product design to ensure that the design plan meets production requirements, improves production efficiency, and reduces costs.
MOQ is 1 pieces, including full – set testing. Before large – scale production, through small – batch sampling and strict testing, we help you verify the product performance and quality and reduce production risks.
A medical project manager will be assigned from the first day to provide you with one – to – one exclusive service, follow up the project progress throughout the process, solve problems in a timely manner, and ensure the smooth progress of the project.
“China Dragon’s implantable PCBA passed our 10 – year accelerated aging tests, far exceeding industry standards!”
—— R&D Director, German MedTech Leader
If you are looking for a reliable partner for Medical Device PCBA Manufacturing, China Dragon Electronics will be your best choice. Contact us now and start the innovative journey of medical technology!
Contact Medical Team | Download Compliance Checklist