With the approach of the 26 May 2020, when the Regulation (EU) for medical devices MDR 2017/745 will be applicable, manufacturers must comply with new regulatory standards and stricter requirements than those imposed by the current MDD. ECM is carrying out its work towards the accreditation as a Notified Body under the new MDR with commitment and responsibility, acquiring more and more competence and, at the same time, planning new services for manufacturers and industry professionals, focusing on the incoming regulatory changes. During the last few months, as well as the regular certification activity according to the MDD, our staff has been involved in several meetings with institutions, notified bodies and other stakeholders to keep updating on the latest regulatory news.

Starting from January 2020, ECM will provide an interesting training program dedicated to exploring the key issues of the future legislative system, for a better understanding of the future changes. The purpose of ECM Training services is to offer medical device companies and experts a prestigious and professional training experience, in order to provide the appropriate tools to deal with the implementation of the new legislation.
In particular, the new ECM courses will be oriented in two different ways: on the one hand, to qualify specialized professionals with the necessary skills in regulatory matters (as also required by Art. 15 of the MDR), on the other hand, to create a training offer for companies that want to deepen specific issues based on their business needs.

ECM, as a Training Body, Notified Body and accredited Testing Laboratory, can boast an Academy division composed of a high skilled staff, specialized in different technical/scientific fields, able to provide top-level training experiences.
The course for experts in regulatory affairs is designed to qualify specialized professionals through the acquisition of advanced skills and a thorough knowledge of the new regulations. This expertise will be ensured by passing a final test and the issue of a certificate attesting the skills acquired.

For more information on the new training plans scheduled for January 2020, please contact our Sales Manager Antonio Balassone at antonio@entecerma.it