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So, what is ISO 13485?

ISO 13485 is an international standard specifically formulated for the medical device industry. It is applicable to the entire product life cycle, including the design, development, production, installation and service links of the product. For electronic manufacturing enterprises in medical electronics assembly, this standard requires highly rigorous capabilities in quality control, risk management, product traceability and process verification.

Enterprises that have passed the ISO 13485 certification, especially PCBA manufacturers with 13485 certificates, must be capable of recording detailed data in each process and achieving full traceability throughout the entire process. This standard is of vital importance for medical PCB assembly and medical PCBA suppliers.

Importance of ISO 13485 in Medical PCBA Manufacturing

Medical equipment needs to meet key medical functions, such as in vitro diagnosis, monitoring of vital signs, surgical assistance, etc. The medical PCBA in these applications must be able to withstand high-intensity continuous operation without any potential safety hazards. That is, these medical PCBA manufacturers must have ISO13485 certification so that the medical PCBA they produce can meet the following requirements:

Full-process document control and record management ensure that medical PCBA manufacturer has the ability of product traceability and quality audit.

Process verification, equipment calibration and personnel training are carried out to ensure that all medical electronics assembly operations are completed under controlled conditions;

Risk assessment mechanism for preventing potential malfunctions;

Material traceability and supply chain control ensure complete transparency from components to finished products.

In a word, the ISO 13485 certificate holds a highly recognized position in the global medical device industry. Then, please allow me to introduce a reliable and leading medical PCBA manufacturer with ISO 13485 certificate to you, that is PCBasic. PCBasic obtained the ISO 13485 certificate many years ago. Now, PCBasic, as one medical PCB manufacturer, excels in quality, compliance, performance, and management.

1. Quality

All medical PCB assembly projects of PCBasic are carried out in accordance with the IPC-A-610 Class III (High-Reliability Level) standard. Ensuring that every medical PCBA meets high-quality benchmarks. In addition, the PCBasic production line is also equipped with advanced devices such as automatic optical inspection (AOI), in-line testing (ICT), X-ray solder joint inspection (suitable for BGA), flying probe testing, and functional testing (FCT). For details, please click: /pcba-testing.html.

2. Compliance

In medical PCB assembly, PCBasic complies with stringent regulatory requirements.

Our production complies with environmental protection regulations such as RoHS and REACH, and all materials used are medical-grade anti-static materials. We strictly control during the component procurement stage to ensure that all parts meet the requirements of medical labels, certifications and tracking.

3. Performance

PCBasic has established and maintained effective processes for design, development, production, and service of PCBs, which helps in delivering consistent and reliable products. We are equipped with highly standardized SMT and THT production lines and ensure consistency through real-time monitoring. Internal auditing, CAPA issue improvement mechanism and SPC statistical process control help us continuously optimize and stay ahead of the medical PCBA manufacturing industry.

4. Management

PCBasic has its own management system, which can detect the production situation of each production line in real-time. In addition, PCBasic can also open an account for customers, so that customers can see: their order’s current process stage (such as surface mount technology, soldering, testing), batch number and serial number tracking, production record archiving, etc..

With years of professional experience, PCBasic can provide you with high quality, high standard, fast medical PCBA to meet all your needs. This PCBA manufacturer with ISO 13485 certificate won't let you down. Welcome to PCBasic! You can know more about PCBasic's certificates from here!

About PCBasic

Time is money in your projects – and PCBasic gets it. PCBasic is a PCB assembly company that delivers fast, flawless results every time. Our comprehensive PCB assembly services include expert engineering support at every step, ensuring top quality in every board. As a leading PCB assembly manufacturer, we provide a one-stop solution that streamlines your supply chain. Partner with our advanced PCB prototype factory for quick turnarounds and superior results you can trust.