Medical Devices

ECM Medical Devices Division can boast a team of highly qualified experts with unique technical and regulatory expertise. Our professional and cutting-edge services are addressed to medical devices manufacturers and suppliers who want to verify the quality and safety of their products, in compliance with European regulations.

ECM Medical Device Division has a deep knowledge of the market and is always up to date with the latest regulatory developments, thanks to continuous training and direct dialogue with other key players in the global regulatory arena.

As a Notified Body for Medical Devices Regulation (EU) 2017/745 (MDR) and Medical Device Directive 93/42/EEC, ECM is an active member of Team-NB – the European Association of Notified Bodies for Medical Devices – and takes part in the periodic coordination and discussion meetings of notified bodies established at European level. Moreover, the ECM experts are invited as speakers at conferences and seminars organised by the various trade associations and stakeholders to provide their experience and expertise on regulatory matters.

Find out all our services in the regulatory field!

Request a service

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EU Certification

Ente Certificazione Macchine is a Notified Body no. 1282 for the European Medical Devices Regulation...

Training for Medical Devices

Our high-quality Training Service has been designed to allow companies and professionals to improve ...