Europeanhhm

Nexstim’s Quality System and NBS 6 Receive MDR Certification in the EU

Thursday, May 18, 2023

Nexstim Plc has received certifications for its quality management system and NBS 6 product under MDR (Regulation (EU) 2017/745) in the European Union. 

The EU quality management system certificate allows for Nexstim to start marketing and selling the NBS 6 system for the treatment of major depression and chronic neuropathic pain within the European Union. Nexstim announced on April 17, 2023, that it had launched NBS 6 in the United States for the treatment of Major Depressive Disorder (MDD).

The NBS 6 enables Nexstim’s unique E-field navigated TMS technology to be used more easily than ever before. Part of this new product generation is an easy-to-use, software-guided application and a modular product design that allows for system capabilities to expand over time and be highly customized based on a customer’s research or treatment interests. 

 
Mikko Karvinen, CEO of Nexstim, comments: 

“The MDR conformity certification is an important step in the process of launching the NBS 6 and achieving one of our key strategic objectives for 2023. I am proud of the hard work our team has put into making the new software generation available in both the United States and the European Union in such a tight schedule. The EU quality management system certification will benefit us in the long term also by making any future product certification processes more efficient.

The NBS 6 received a great response as we attended and unveiled the product at the Clinical TMS Society Annual Meeting in Colorado Springs, United States earlier this month. We are expecting nothing less from the European market and are excited to continue the promotion work.”
 

 

Source: .nexstim.com

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