Why does medical PCBA need ISO13485 qualification certification

Pcba circuit boards have been used in all aspects of public life, basically everywhere. Especially with the development of medical science, more and more medical research and treatment methods can benefit the public through the improvement of medical equipment. Among them, the technical driving force of medical electronics is also mainly due to the improvement and optimization of the smt processing technology, which directly promotes the maturity and stability of the PCBA manufacturer control board.

However, the role of medical equipment is mainly to intervene in time when the patient's life is at stake to save lives. During critical, life-saving medical procedures, there must be no instrument failure. Then these instruments must be manufactured in accordance with very strict standards. There is no doubt that these devices are key nodes. Whether they can work stably is not only a scientific question, but also a practical consideration.

 

Therefore, strict access qualifications must be followed in all links of medical electronic PCB OEM materials. This is another very important requirement of pcba processing plants. This is also the basic starting point of the ISO13485 medical electronic qualification certification currently used worldwide. This standard is consistent with the ISO 9000 series and also specifies the quality and reliability of medical products. According to this standard, specific standards for documented procedures and tracking materials have been formulated. Some important aspects of ISO13485 include:
 
1. The certification requires the manufacturer to record all manufacturing link data in order to control the production process in accordance with the standard
2. It also specifies the details of risk management and control procedures.
3. The manufacturer needs to have an audit system to track the smt processing plant's own process in the entire process.
4. ISO 13485 certification also means that medical device manufacturers understand and meet the regulatory requirements in the certification content and can meet the requirements of regulatory agencies.
 
With these standards, the processing needs of regulatory agencies and customers are basically met, and manufacturers are fully capable of completing the stable quality of such products, and have the necessary systems and processes. Therefore, only medical pcb assembly smt assembly manufacturers that have obtained ISO13485 qualification certification can perform corresponding product production.

POE Technology has consistently restricted the production team, engineering team, and purchasing team in accordance with the highest industry standard certification requirements, and has long-term accumulation of experience and professional process knowledge in medical pcba assembly. In terms of hardware investment, we are also equipped with testing equipment purchased from all parts of the world to ensure that the process requirements of each product are met on the basis of hardware. Choosing us is to choose peace of mind, caring, and rest assured.