Nearmedic has confirmed that its quality management system for the production of the ESVIEF (stromal-vascular fraction separation system) medical device meets the requirements of international standards. The company has obtained certificates of compliance of the ESVIEF medical device production with the requirements of the EN ISO 13485 and EN ISO 9001 international standards.
The EN ISO 13485 standard confirms the international level of quality management system typical for the medical device industry. Its updated version approved in 2016, this standard meets the current level of technology and regulatory requirements, and also supports the level of expectations of medical device consumers.
The ESVIEF line of medical devices for the isolation of autologous stromal-vascular fraction from human adipose tissue is a single-use sterile kit that includes a device for separating cell fractions and an enzyme for tissue processing. The ESVIEF medical device is currently being registered and will soon be launched on the Russian market.