3D-lipo Ltd achieve new certification


Aesthetics equipment company 3D-lipo Ltd has achieved EN ISO 13485:2016 certification in line with changes in Medical Device Regulations to be implemented later this month.

From May 2020, the new directives mean that 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 notified body.

The EN ISO 13485:2016 certification specifies requirements for a comprehensive level of quality, whereby an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. This is then further reinforced through inspection by the Medical & Healthcare Regulation Agency (MHRA).

As part of a two-year project, 3D-lipo Ltd have developed and embedded a complete Quality Management system. Following auditing by BSI (British Standards Institution), this work has culminated in the achievement of EN ISO 13485:2016 certification earlier this year.

Speaking of the news, Roy Cowley, managing director of 3D-lipo Ltd, says: “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."