On10th April 2018, ECM Ente Certificazione Macchine was formally accepted as the newest member of TEAM-NB, the European Association for Medical devices of Notified Bodies. Team-NB was founded in 2001 and includes 24 Notified Bodies members from 12 different European countries.
Membership in Team-NB represents an important international recognition and a great opportunity to advance dialogue with others Team-NB members. The primary objective of the Association is to pursue transparency and communication between Notified Bodies and to support the sharing of relevant information in regulatory field, such as guidelines, regulations and new standards. The association’s mission is to promote innovation and technological development in the medical device market, on the basis of a strong normative frameworks that ensure quality, safety and efficacy of the medical devices brought to market.
What does it mean to be a Team-NB Member?
- Being part of a recognized association which protects the interests of Notified Bodies,
- Playing an active role in the review of new guidances and impacting the regulation process,
- Attending to periodical meetings and working groups on specific issues, staying up-to-date on the latest news in regulatory matters.
What are the advantages for manufacturers who work with a Team-NB Member Notified Body?
Ente Certificazione Macchine, as Team-NB Member, has access to periodical reports, guidelines and detailed documentation provided by the Commission and the working groups. This provides ECM with significant support for carrying out our Notified Body activities effectively and efficiently. The selection of your Notified Body is an important decision. The strategic partnership between a Notified Body and the manufacturer deeply impacts both your brand and time to market. The certification of medical devices is essential for manufacturers to build and maintain public confidence in their products. Working with a Notified Body that is member of Team-NB means you can rely on that Notified Body to have accredited competences; be attentive to manufacturers needs and market developments; and to be a strong promoter of innovation, supported by solid data on safety and effectiveness of performance.
For more information, visit the website www.team-nb.org