Last 26 June, ECM took part as Notified Body for medical devices in RADAY, an important training day involving companies and notified bodies. The Regulatory Affairs Day, organised by Confindustria Dispositivi Medici, was attended by over 300 professionals from medical device and healthcare industry.

An intensive working program, to provide manufacturers with all the information necessary to better understand the new regulatory environment and the new requirements established by the new European regulations.

“The aim of the event was to bring together the top experts from notified bodies, in a moment of information to support the industry towards the transition to the changes introduced by the MDR 2017/745 and the IVDR 2017/746″ says our Sales Manager Antonio Balassone “and thanks to the collaboration of the NBs and companies, the workshop was a great success”.

Our Technical Expert Tatiana Vignudelli held a conference for ECM. “During the time at my disposal, I have analyzed the assessment procedure according to Annex IX, from its application on devices according to the different class of risk, up to the special procedures for some types of medical devices,” explains Dr. Vignudelli.

Many technical and regulatory issues have been discussed by professionals of major certification bodies, in order to provide participants with the operational tools to address the new regulatory challenges.

We would like to thank all the companies that took part at the event, the colleagues from the Notified Bodies and Confindustria Dispositivi Medici, for having organized such an important moment of exchange and training, facing the transformations that are affecting the world of medical devices.

For more information about our certification services, you can contact our Sales Manager Antonio Balassone at antonio@entecerma.it or at +39 393 2471040