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FASTPCBA won the IS013485 “Medical Device Quality Management System” certification

1,078 Published by FASTPCBA 5月 30,2019

FASTPCBA won the IS013485 “Medical Device Quality Management System” certification

ISO13485 is also called “medical device quality management system for regulatory requirements”. Because medical devices are special products for life-saving, disease prevention and treatment, it is not enough to standardize only according to the general requirements of ISO9000. For this reason, ISO organization has issued ISO13485 system standard. Special requirements are put forward for the quality management system of medical device manufacturers, which has played a very good role in promoting the safety and effectiveness of medical devices.

After over one month severe review, FASTPCBA officially passed the IS013485 system certification, which has established a comprehensive and strict quality management system for medical device manufacturing, ensuring that we meet the necessary regulatory requirements for medical equipment PCB assembly.

Scope of quality management system certification: Production of PCB components for electrocardiograph and endoscope.Through IS013485: 2016 certification, it not only proves that under the quality assurance system, FASTPCBA can continuously provide high-quality products that meet the needs of medical device customers, and further demonstrates our company’s higher requirements for product quality standards. The successful passing of this IS013485: 2016 certification is an endorsement of our company’s product quality and safety regulations aspects.

FASTPCBA will continue to maintain the refined management mode, further improve the management mechanism, and strive to create better quality, higher-end products! At the same time, make the company continue to develop in a better direction.

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