2025 MONITORING AND DIGITALIZATION
During the session, the 2025 monitoring results were presented, featuring a detailed analysis of the most frequent non-conformities identified during surveillance activities. This moment of institutional transparency is essential for raising the overall quality of national production
Significant focus was placed on digital transformation, featuring strategic updates on:
UDI System: enhancing unique device identification for full traceability;
EUDAMED: the state of the art of the European database.
ECM’S COMMITMENT TO ITS CLIENTS
Participation in this meeting is not merely an institutional duty, but a guarantee of quality for all ECM partners. Being updated ‘at the source’ on the latest ministerial directives allows us to support manufacturers with precise and timely technical consultancy, reducing uncertainties throughout the certification process.
Your Partner in Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our broad expertise, we help organizations comply with laws and regulations, ensure quality, and continue to innovate with confidence.
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ECM – Ente Certificazione Macchine is informed of the existence of fakes/counterfeit certificates/laboratory test reports/other ECM documents relating to certain European Directives or International Standards. No one has permission to issue certificates or other documents in our name and on our behalf, so ECM will take action against any companies that issue certificates/documents without authorization.
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UPDATED LIST OF IMPROPER USES OF THE NAME ENTE CERTIFICAZIONE MACCHINE SRL AND/OR THE ECM NUMBER OF NOTIFIED BODY 1282
To consult the updated list of reports of misuse of the name Ente Certificazione Macchine srl and/or the notified body number 1282, click here.
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IMPORTANT NOTICE: Immediate suspension of the use of the product “Hyperbaric chamber”
We would like to inform all our valued customers and business partners of an urgent measure that requires the utmost attention and timely cooperation from all users.