Team-NB

medical devices

About

Team-NB is the European Association of Medical Devices Notified Bodies, established in 2001. It consists of 44 members from 20 countries across Europe. The association's mission is to ensure high levels of patient safety and confidence in medical devices and in-vitro diagnostic products by promoting innovation supported by solid safety and effectiveness data. Team-NB focuses on promoting innovation in medical devices, supporting notified bodies with guidance documents, and driving continuous improvement of medical products. It serves as a unified voice for Notified Bodies in communications with the European Commission and other stakeholders. The association develops guidance documents on EU medical device regulations, organizes training sessions, and facilitates dialogue with regulatory bodies. It also publishes position papers and best practice guidance to assist in regulatory processes. Team-NB plays a vital role in enhancing patient access to safe and innovative medical solutions across Europe.

Technologies

Outlook Microsoft Office 365 Gravity Forms Apache WordPress.org Google Font API Mobile Friendly reCAPTCHA AI

Keywords

medical equipment manufacturing eu medical device regulation udi medical device certification medical device regulation eu regulations risk management ivdr conformity ivdr performance testing ai in medical devices eu mdr compliance regulatory compliance eudamed in-house device regulation notified bodies medical equipment and supplies manufacturing b2b medical technology regulatory updates legacy device transition mdcg guidelines eurl involvement in ivd regulatory guidance documents notified body standards clinical evaluation european commission surveillance audits digital health regulation medical device safety standards ivdr

Location

20 Rue Bawepuce, Sprimont, Walloon Region, Belgium, 4140

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