In the development of our company, we actively advocate taking the market as the guidance, service as the engine, innovation as the driving force, reputation as the foundation, and actively expand the domestic and foreign Full Range Pcba Smt Service, Components Sourcing, Medical Product Printed Circuit Board Assembly And Design market. We continue to strengthen our brand building, attract, retain and motivate talents, enhance the competitive advantage of human resources, and promote the growth of our company. That has a sound business credit history, outstanding after-sales service and modern producing facilities. By improving the operation efficiency and achieving the relative balance of profit, growth and risk, our company finally improved the operation performance level. In line with the customer-oriented principle, we have established a sound modern enterprise system and a complete and effective total quality management system, as well as a prompt and thoughtful pre-sale and after-sales service system.
1.ISO13485 Prototype PCB Assembly Intriduction
In the realm of medical device manufacturing, ISO13485 certification stands as a testament to a company's commitment to quality and compliance. This international standard, specifically tailored for the medical device industry, ensures that manufacturers adhere to rigorous guidelines throughout the product lifecycle, from design and development to production and post-market surveillance. When it comes to prototype PCB (Printed Circuit Board) manufacturing, ISO13485 plays a crucial role in guaranteeing the safety, efficacy, and regulatory compliance of medical devices.
2.Key Elements of ISO13485 Prototype PCB Assembly
- Risk Management: ISO13485 emphasizes the importance of risk management throughout the product lifecycle. In prototype PCB manufacturing, this involves identifying potential hazards and mitigating them through design and production controls.
- Design and Development Controls: The standard requires manufacturers to establish and maintain robust design and development controls. This includes ensuring that prototype PCBs are designed in accordance with medical device regulations, undergo thorough testing and validation, and are capable of meeting the specified performance requirements.
- Production and Process Controls: ISO13485 mandates that manufacturers implement strict production and process controls to ensure the consistent production of high-quality prototype PCBs. This includes monitoring and measuring key process parameters, conducting regular audits and inspections, and maintaining detailed records of all manufacturing activities.
- Purchasing Controls: The standard also requires manufacturers to establish and maintain effective purchasing controls to ensure that all raw materials and components used in prototype PCB manufacturing meet the required quality standards.
- Post-Production Activities: ISO13485 emphasizes the importance of post-production activities such as final product inspection, testing, packaging, labeling, and storage. These activities ensure that prototype PCBs are ready for use in medical devices and comply with all relevant regulations.
3.ISO13485 Prototype PCB Assembly Benefits
- Improved Product Quality: Through rigorous quality control measures, ISO13485 helps manufacturers improve product quality and reliability, thereby enhancing customer confidence in their products.
- Compliance with Regulatory Requirements: ISO13485 certification ensures that manufacturers' PCB assembly processes comply with the regulatory requirements of the medical device industry, helping to avoid potential legal risks and compliance issues.
- Enhanced Market Competitiveness: Manufacturers with ISO13485 certification are more competitive in the medical device market as they can provide high-quality products that meet international standards.
- Promotion of Continuous Improvement: ISO13485 encourages manufacturers to continually seek improvement opportunities by regularly auditing and assessing their quality management systems to optimize production efficiency and product quality.
4.About BQC
Our factory is a PCBA manufacturer/SMT/EMS factory, we have our own design team so we can do both OEM and JODM.
We have been serving in EMS industry for 21 years.

We have:
22 SMT lines; 4 THT lines; 3 assembly lines.
YAMAHA SMT and each line equipped with SPI, AOI machine.
X-ray machine in SMT workshop and ICT/FCT test machine in DIP workshop.
one individual conformal coating room.

5.BQC Core Value
Be Honest: Don't cheat customers, Don't cheat colleagues, Don't cheat suppliers
Share: share profit with all employees, and welcome excellent management staff to hold share of the company.
Feedback: Take carbon peaking and carbon neutrality as the goal, powered by innovation and based on energy storage to feed back the country and society.
Customer-first: Opposing taking the boss, R&D, and manufacturing as the center. Taking customers representative as the center internally, and taking customers as the center externally.
6.FAQ
Q1: What's your factory size?
A1: We have factory area of 13000 SQM with total 800 employees.
Q2: How many production line in your factory?
A2: 22 SMT production lines, 4 THT production lines, 4 Hand soldering lines, 3 Final assembly lines,
After years of hard work, our Custom Lighting Aluminium PCBA Board Prototype SMD LED PCB Board has been recognized in the global market, and is favored by more and more customers for its stable product quality and reasonable prices. We hope to achieve the lowest cost, the highest efficiency and the best integration of resources, making the maximum benefit of the enterprise. Relying on domestic and foreign high-tech enterprises as the market, our company has won a good reputation among new and old customers.
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