We are proud to announce that ECM has officially obtained the extension of its ISO 17021 accreditation for the Quality Management Systems certification scheme according to the EN ISO 13485:2016 / UNI CEI EN ISO 13485:2021 standard, specifically for the medical device sector.

This extension represents a fundamental step forward in our mission to provide high-profile certification services, ensuring manufacturers a solid and competent partner for the compliance of their processes.

NEW ACCREDITED TECHNICAL AREAS

The extension specifically covers sterilization activities, a critical process for medical device safety. As of today, ECM is accredited to certify the following technical areas:

• 1.5.A. Ethylene Oxide Gas Sterilization (EOG);

• 1.5.B. Moist heat sterilization;

• 1.5.D. Radiation sterilization (e.g., gamma rays, electron beam).

WHY CHOOSING ECM CERTIFICATION?

An accredited ISO 13485 certificate is not just a matter of compliance, but a hallmark of reliability and safety in the global market. Thanks to this extension, ECM confirms its position as a leading body for companies seeking a serious, authoritative certification path focused on technical excellence within the medical sector.