At 3D-lipo we’re proud to announce that we have recently appointed ISO Co-Ordinator, Aimee Downing to guide our ever-expanding company through the changes recommended to meet the requirements of the medical device regulations and ISO 13485.
Roy Cowley, Founder and MD at 3D-lipo told The Consulting Room Magazine that “Technology must perform, but must also be safe, and as a company, we take pride in producing quality machines, so when changes came about in medical device regulation, we knew what we had to do. There are two major regulation changes happening which affect us, as a manufacturer of ‘cosmetic’ devices.
At 3D-lipo Ltd we have responded positively to these changes and instigated a holistic upgrade to our company operations to bring in a new ISO 13485 compliant QMS and to ensure all our products can be CE marked under the new MDR requirements as medical devices”.
We’d be lying if we said we could introduce procedures specific to our company and in a time frame that meets all the requirements without the expertise of a dedicated ISO Co-Ordinator, so this year we hired Aimee Downing, ISO lead auditor and practitioner certified by the Chartered Quality Institute.
Aimee has a strong background in engineering with rail companies management systems and has already been working closely with the 3D-lipo team to ensure the processes and quality management systems are in place ahead of the upcoming visit from an ISO Auditor.
Aimee will be training our staff and auditing our processes to make them ready for the (CE) Notified Body audits which are necessary to prove conformity and allow us to comply with the regulations for selling medical devices in the UK and Europe.
By aligning ourselves with the medical device regulations and ISO 13485, which must be cemented by May 2020, we are ensuring that 3D-lipo will remain a robust organisation and market leaders within the beauty and aesthetics industry.
Aimee said “The introduction of ISO 13485 and the Medical Device Regulations offers a huge opportunity for 3D-lipo to change the structures of the business and cement our place as a market leader in the aesthetics industry. I am excited to be part of this evolution and bringing my diverse skills to help the 3D team to achieve this. Quality is important for every business and requires both individual contribution and strong team culture in order to achieve the end goal.”
So, What Does This Mean for Practitioners and Therapists?
Well, complying with regulatory requirements will provide a manufacturer with greater market access. The penalties for non-compliant devices are simply not worth risking. Our increased supplier control and post-market follow up, plus how we deal with issues when they arise, will lift our customer service to new levels, and allow us to move more quickly to bring new and improved products to market. Compliance with ISO 13485 is the only way in which we can operate once the MDR fully transitions, as all our products will be classed as medical devices from that point.
Our early preparation will make sure our customer base can be assured that we will provide a seamless process over the next few years as the marketplace goes through enormous upheaval. Some cosmetic device suppliers will not be able to make the transition successfully, due to a lack of time or competence, or not being willing to make the investment. Where will they, and their devices, and more importantly their customers be then? Change like this is both disruptive and confusing, we will be able to provide purchasing checklists for our customers so they can check whether other suppliers are compliant and ask deeper questions of those who wish to sell them devices.