When considering an investment in capital equipment for your clinic, you should only purchase from reputable companies who are committed to supporting their customers.
Those investing in technology-based devices should be familiar with the new Medical Device Regulations, and ensure that their chosen supplier or distributor is compliant with the new regulations.
When purchasing machines, consider what extra services manufacturers can provide, including marketing support, and access to resources like business development managers, full technical support, and training.
Non-surgical face & body systems are high-tech devices that will require ongoing maintenance, so it is important to also consider the quality of the manufacturer guarantees and service contracts that are offered, in addition to any ongoing costs.
We are an EN ISO 13485:2016 certified company and offer a robust support system, allowing you to have total peace of mind when investing in our equipment.
Medical Device Regulations
Following the implementation of the Medical Device Regulations, companies are required to demonstrate their compliance by developing and embedding a comprehensive, independently audited quality management system.
At 3D Aesthetics, we are one of the few companies in the industry to have achieved our EN ISO 13485:2016 certification in line with changes in Medical Device Regulations.
What is EN ISO13485:2016?
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.
This standard 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.
A Certified Company
As part of a two 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 close auditing by BSI (British Standards Institution), this work culminated in the achievement of EN ISO 13485:2016 certification in February 2020.
What Does This Mean For Our Clients?
This accreditation gives our customers absolute confidence that 3D Aesthetics always work to exceed customer expectation and maintain our dedication to continual improvement. It ensures that all of our equipment, and support provided, meet certain specifications; safety and reliability standards as required by legislation.
Why is This Important?
We are one of the few companies within the UK Beauty & Aesthetics industries to receive our ISO certification ahead of the new regulatory regime imposed by the Medical Device Regulations. As a customer of 3D Aesthetics, you can have total peace of mind that you are investing in a company that is regularly audited to ensure high quality and customer service standards.
Excellence, driven by a quality focused approach, is our strength and is a dynamic duo to catalyse our continuing improvement as an organisation.