Aesthetic device manufacturer 3D-Lipo Ltd has achieved the EN ISO 13485:2016 certification in line with the Medical Device Regulations that will be implemented on May 26.
Following the implementation of the Medical Device Regulations, equipment suppliers will be required to demonstrate their adherence to the regulations by developing a comprehensive quality management system, which is independently audited by an external body.
The certification specifies requirements for a standard level of quality of devices and services, which is then reinforced though inspections by the Medical and Healthcare Regulation Agency (MHRA).
Roy Cowley, managing director of 3D-Lipo Ltd said, “This accreditation is fantastic for 3D-lipo Ltd because by integrating our quality management system within the business, this has significantly improved our operations. Our customers can now have the confidence that we are not just saying that we are great, but that we have been independently certified to demonstrate this”