- Who we are
- Customer area
- Work with us
The year 2022 of ECM began with a great challenge: reorganising the Company with a Sole Administrator, taking on the difficulties of the post-pandemic and the objectives set. A test successfully passed and which allowed the Company to grow even stronger.
Thanks to the commitment and perseverance that have always distinguished us, ECM was able to reach important goals in 2022 and consolidate its authority on the international regulatory scene.
The success of ECM is due to its team and its ability to work together, because this is what makes ECM a great company: people. Always doing their best to achieve the shared objectives, each member of ECM’s staff plays a fundamental role, with the awareness that only through collaboration and mutual trust is it possible to get great results.
If ECM has been able to overcome the difficulties of the pandemic and is now able to face the challenges of the future with renewed hope, it is only thanks to a unique and irreplaceable team.
In 2022, ECM completed an important milestone: the designation as Notified Body No. 1282 for the Medical Devices Regulation (EU) 2017/745. After a long accreditation process, ECM can now provide medical device manufacturers with the MDR conformity assessment service.
In light of the delicate transition phase that the entire medical sector is going through, the role of ECM is even more fundamental. Indeed, notified bodies have the duty to support the system in the transition to the new regulatory regime, evaluating with competence and professionalism the devices that will be placed on the EU market. ECM is also an active player in the decision-making process that will define the future legislative framework, participating in first person in the working groups and institutional updates that take place at an international level.
With a strong international reputation, ECM set up two new companies in 2022: Ente Certificazione Macchine UK Ltd, based in the United Kingdom, and Ente Certificazione Macchine USA Corp, based in the United States. Two new realities created to provide efficient and professional services to companies interested in reaching the UK and American markets, as well as companies wishing to export their products to the European market.
In addition, ECM’s presence in China is being strengthened through new partnerships with prestigious local companies, to guarantee an even more targeted and efficient service.
ECM has always looked to the future with enthusiasm, setting new goals for 2023 as well. Always attentive to the latest market trends and company needs, ECM aims in the coming year to enhance its Testing Laboratory with new equipment and new partnerships with international laboratories, in order to guarantee an ever wider range of tests and trials.
In consideration of the designation as Notified Body for the Medical Devices Regulation (MDR), our Medical Devices Division is already working on expanding its scope, with the aim of further increasing the range of devices that ECM can certify. With this purpose, in 2023 our staff will be enriched with new experts who will contribute in their respective areas of expertise.
The strength and reliability of our group allows ECM to expand, set new goals and invest in cutting-edge services and activities, opening the doors to all those professionals who want to become part of a solid and successful team. Thanks to this solidity, ECM is already planning new accreditations to further expand the range of its certification services.
As we do every year, we would like to thank all our staff, as well as our customers and collaborators, who place their trust in us every day and enable us to continue to provide an attentive and high-quality service.