ECM - Medical Devices (Ente Certificazione Macchine)

With 30 years of experience in certifying products, machinery, and work equipment, Ente Certificazione Macchine (ECM) provides high-quality certification, testing, inspection, and training services to a wide range of international companies.

🏥 Since February 2017, ECM has been a trusted partner for medical device companies seeking certification in compliance with the Medical Device Directive MDD 93/42/CE.
On 14 October 2022, ECM was designated as Notified Body for Medical Device Regulation (EU) 2017/745 by the Italian Ministry of Health.

ECM - Medical Devices Division is 🔬
- Notified Body #1282 for Medical Device Directive 93/42/EC and MDR (EU) 2017/745
- Accredited Testing Laboratory ISO/IEC 17025
- Certification Body for Quality Management System for the standard ISO 13845

🌐 ECM’s mission is to ensure that manufacturers will market safe, high-quality and compliant devices, through efficient certification and testing services.

We also provide Audit and Certification for QMS for the standard ISO 13485 and Testing services accordingly to IEC 60601 standard.
Through our commercial offices and extensive partner network in Europe, Asia and America, ECM delivers reliable and efficient services to global companies.

For further information 📧 please contact our Sales Department:
➤ Diego Stevanella
[email protected] | mob. (+39) 393 2471040
➤ Marzia Pellegrini
[email protected] | mob. (+39) 392 0710386

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