Our journey in obtaining crucial certifications began in 2010, just two years after our establishment as a hearing aid manufacturing factory in Putian. Understanding the significance of quality assurance in the medical device industry, we set our sights on achieving ISO 13485, the internationally recognized standard for medical device quality management systems. It took us a year of meticulous preparation, upgrading our production processes, and training our staff. Finally, in 2011, we proudly received the ISO 13485 certification, which not only validated our commitment to quality but also opened doors to more serious business discussions with international partners.
In 2013, as we aimed to penetrate the European market, we know that the CE marking was non-negotiable. We dedicated months to ensuring that our products met the stringent safety, health, and environmental protection requirements of the European Union. Our R&D team worked tirelessly to modify product designs, and our quality control department enhanced testing procedures. The hard work paid off when we were awarded the CE certification in 2014, enabling us to display the CE mark on our hearing aids and enter the competitive European market.
As we entered the 2020s, we aimed to improve workplace safety and employee well-being. In 2021, we achieved the OHSAS 18001 certification (now rebranded as ISO 45001) for occupational health and safety management systems. This certification was a result of our efforts in providing comprehensive safety training, improving workplace conditions, and establishing effective emergency response procedures.
CE certificate
CE report
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medical
MSDS