How Suzy Glam meets UDI and MDR compliance with Mediclabel
How eyewear designer Suzy Glam meets strict UDI and MDR requirements with a simple, personal barcode labeling solution.
Suzy Glam strikes a new path when it comes to designing eyewear. Instead of starting from a drawing or a computer render, every model is shaped by hand first, then fitted and adjusted, so the design is literally formed on the face. Suzy Glam believes this three dimensional approach produces a different, more balanced result than the traditional two dimensional way of designing.
How Suzy Glam meets UDI and MDR compliance with Mediclabel
Who is Suzy Glam
Suzy Glam was founded in 2013 by Etienne Frederiks and Susanne Klemm, who brought together decades of experience in the optical world. Etienne has worked as an optician, purchaser and eyewear entrepreneur since 1990, while Susanne is a Swiss born designer and optician who built an international career in contemporary jewellery design. Combining her three dimensional design skills with his optical expertise, the two joined forces to create Suzy Glam.
What they do
Suzy Glam strikes a new path when it comes to designing eyewear. Instead of starting from a drawing or a computer render, every model is shaped by hand first, then fitted and adjusted, so the design is literally formed on the face. Suzy Glam believes this three dimensional approach produces a different, more balanced result than the traditional two dimensional way of designing.
The outcome is a collection that combines a strong presence with a superb fit, styles that work equally well as an object and as an accessory. Suzy Glam knows the history of eyewear, but wants to go beyond retro and create pieces for a new generation of eyewear lovers, both women and men. The female styles have a powerful, feminine character, while the men's collection is made for confident individuals who are not afraid to show themselves.
What they were looking for
As a manufacturer of eyewear, Suzy Glam also qualifies as a manufacturer of medical devices, and therefore has to comply with the MDR (Medical Device Regulation) and the related UDI (Unique Device Identification) requirements.
Suzy Glam was looking for a way to generate compliant GS1 barcode labels for its products, without having to invest in complex IT systems or specialised hardware. The solution needed to be simple enough for the whole team to use, across every location, while still meeting the strict requirements around patient and product safety.
The solution we offered
Type 2 Solutions introduced Suzy Glam to Mediclabel, the GS1 barcode label solution built specifically for the healthcare and pharmaceutical industries.
With Mediclabel, Suzy Glam can generate compliant labels using standards such as GS1 128 and Data Matrix, so every pair of glasses meets the GS1 and UDI/MDR requirements. Because Mediclabel is fully web based, no special hardware or software is needed, which made implementation fast and straightforward. A single subscription allows multiple users to generate labels from every location, with all label and product data managed centrally.
Mediclabel is a product of Type 2 Solutions, a GS1 Solution Provider for both GS1 Netherlands and GS1 Belgium and Luxembourg.
What Suzy Glam thinks of the collaboration
"We have been using the Mediclabel software for a few years now, a little out of necessity really, because we have to comply with European legislation. But we really appreciated how clearly you explained everything, because we are an eyewear designer and manufacturer, and the Medical Device Regulation was completely new to us. It was very clear how you supported us, and how easily the whole process went. And also that when issues do come up, there is a real point of contact, a personal one. In this day and age that is rare, and really wonderful."
Susanne Klemm, Suzy Glam
.avif)
.avif)
