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The importance of ISO 13485 certification to medical PCBA circuit boards

date:2021-07-23 11:28:33

PCBA circuit boards have been used in all aspects of people's lives, 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 control board. PCB multi-layer proofing is widely used in the medical electronics industry. This is also the technical basis for the development of medical electronics.

However, the role of medical equipment is mainly to intervene in time when the life of the patient is in danger, saving 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 PCBA electronic foundry materials. This is another very important requirement of medical PCBA processing plants. This is also the basic starting point of the ISO 13485 medical electronics qualification certification currently accepted 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 ISO 13485 include:

The certification requires manufacturers to record all manufacturing link data in order to control the production process,

It also specifies the details of risk management and control procedures.

Manufacturers need to have an audit system to track the smt processing plant's own processes throughout the process.

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 requirements 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 smt chip processing manufacturers that have obtained ISO 13485 qualification certification can perform corresponding product production.

FASTPCBA obtained the ISO 13485 qualification certification in 2011, and at the same time, it has consistently restricted the production team, engineering team, and procurement team in accordance with the highest industry standard certification requirements. Has long-term accumulation of experience and professional process knowledge in medical PCB circuit board production and medical PCBA. 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.


FASTPCBA 20 years' experience for PCB Assembly.

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