We have been working to achieve our EN ISO 13485:2016 certification in line with changes in Medical Device Regulations which will be implemented from May 2020.
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. This is amazing for our brand, as it ensures that we are now reaffirmed as being leading marketeers but it also aligns us with having high standards of operation and a long-term commitment for quality delivery. For the industry as a whole, it demonstrates that from small beginnings, the industry is growing. Therefore, this requires the framework of a consistent structured approach and through the process, this will enable growth without compromise”
What are these changes and what do they mean for Equipment Suppliers?
Following the implementation of the Medical Device Regulations in 2020, equipment suppliers are required to demonstrate our adherence to the regulations by developing a comprehensive quality management system, which is independently audited by an external notified body.
What is EN ISO13485:2016?
BS EN ISO 13485: 2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes 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 an audited standard specific to the medical device industry, which is further reinforced through inspection and close scrutiny by the Medical & Healthcare Regulation Agency (MHRA) who oversee industry compliance with the Medical Device Regulations.
As part of a 2-year project, we have developed and embedded a complete Quality Management system which has cemented our position at the forefront of the Aesthetics industry.
Following auditing by BSI (British Standards Institution), this work has culminated in the achievement of EN ISO 13485:2016 certification in February 2020.
What does this mean for clinics?
This accreditation gives clinic owners absolute confidence that we always work to exceed their expectations and maintain our dedication to continual improvement. It ensures that all of our equipment, and support provided, meet certain specifications; safety and reliability standards required as part of the regulatory framework.
At 3D-lipo Ltd, we are one of the few companies within the UK Beauty & Aesthetics industries to receive our certification ahead of the new regulatory regime imposed by the Medical Device Regulations from May 2020.
Excellence, driven by a quality-focused approach, is our strength and is a dynamic duo to catalyse our improvement.