Ce CertificatesIntelligo BV
IntelliGO BV, Ce & Iso
Safety and quality are non-negotiable in the medical devices industry that’s why we developed ISO 13485.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Intelligo BV has adopted the EN ISO 13485:2016-04 procedures. .
CE marking is the medical device manufacturer's claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union. Intelligo BV has obtained CE Mark for intelliGO FREE CGM.
ISO compliance generally isn't a one-time thing, as organizations are encouraged to perform ongoing compliance monitoring. Intelligo BV follows the act of reviewing and maintaining compliance. In this way, an environment of continuous improvement to processes and procedures is being achieved.