Following the recent news regarding the bankruptcy declaration of TÜV NORD Scandinavia, we know that many manufacturers are now facing a period of severe uncertainty and the urgent need to ensure the regulatory continuity of their products.

In a dynamic and highly regulated sector like medical devices, you cannot afford disruptions that compromise your market access.

If you are looking for a solid, well-structured Notified Body (NB) with immediate operational capacity, Ente Certificatore Macchine (ECM) is the partner you need.

WHY CHOOSE ECM?

Our operational and technical teams are ready to accept all MDR application transfers for legacy devices from Swedish companies in need of a rapid, secure, and seamless transition.

Here is what we offer our partners:

• Immediate Operational Capacity: We have the resources and structure to take on your projects without indefinite waiting lists.
• Responsiveness and Flexibility: We understand the operational complexities of the sector and work alongside you to provide timely responses.
• Focus on Time-to-Market: Our goal is to ensure that your medical devices continue to reach the market on schedule, in full compliance with the MDR (EU) 2017/745 Regulation.

Do not let market changes slow down your growth or compromise the compliance of your products.

Contact us today to discuss the transfer of your applications and plan your MDR strategy together with our team of experts.

Ing. Diego Stevanella ✉ diego.s@entecerma.it    (+39) 3932471040