Last 6th February, the annual convention dedicated to the medical field was held in Tel Aviv – Israel, focused on three main issues: Clinical Studies, Medical Device Regulation, Pharma Regulation. ECM has been invited to participate at the congress to bring its contribution in the regulatory field as Notified Body for EU Medical Device Directive and QMS 13485 Certification Body.
ECM presentation on “The new European regulation (MDR), from a Notified Body perspective” given by Mr. Andrea Secchi – CEO of ECM – and Mrs. Vanessa Biavati – Chief Technical Engineer for ECM Medical Device Division, attracted the biggest number of attendances, with a huge feedback and interest.
In particular, the conference was around two different topics:
- ECM technical expert Mrs. Biavati provided an overview of the new Medical Device Regulation(MDR), focusing on the main changes from the MD Directive 93/42/EC. Many interlocutors expressed their interest asking for more information and further insights, in order to better understand the difficulties and the tricky issues regarding the transition.
- The conference was also an occasion for ECM to introduce the new ECM service JIT – Just in Time, a revolutionary program that enables companies to achieve theCE Certification in only 2 weeks!
The congress and following one-to-one meetings with medical device companies and leading quality and regulatory consultants allowed ECM to develop its international business, providing competence, experience and support to Israeli medical device professionals. Attending the congress also ECM Area Manager Mr. Avi Hirshnzon, which represents ECM in Israel. “The success of ECM intervention has been reflected in the significant number of applications for CE and ISO 13485 Certification required following the conference” says Mr. Hirshnzon “Here in Israel ECM is highly appreciated for our competence and reliability and our international prestige makes us an important reference point for CE medical device regulation activities”.
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