atrifys success is built on working closely together with the community of manufacturers, their trading partners, regulatory bodies, and trade association. To further streamline this approach, we recently transformed our MDR Implementation task force into a regular UDI Regulatory user group, whose objective is to review with the Industry the requirements coming from emerging regulations (for instance China, South Korea, Saudi Arabia...) as well as EUDAMED/MDR in Europe and the GUDID in the US, and how to best approach them with consistent solutions. Addressing priorities agreed by the group members, this is a unique area of collaboration and information sharing to ensure we have the same understanding of the regulations, speak consistently to the outside world and develop the best connectors to enable product content registration. The first meeting brought 28 people together in a conference call.
This UDI regulatory user group is complementary to the GDSN user group for Medical devices, which got created in 2019 at the request of leading manufacturers in this area. Both groups are open to any atrify customer interested in getting the full benefit of leveraging product content exchange with regulatory UDI databases and trading partners and share information with their peers. Those groups are industry driven, and the GDSN user group is chaired by B Braun.
For any further information, please contact our Director of Strategic Industries Lionel Tussau, in charge of Healthcare at atrify, who is facilitating those user groups.
