Eletech, Head of the International Design Centres, Group’s R&D Division, is proud to announce the extension of its ISO 13485:2021 certification, which now officially covers the: “Design of medical devices and medical equipment based on customer specifications”.
This milestone reinforces our commitment to quality, safety, and reliability within the highly demanding medical device sector.
The ISO 13485:2021 standard defines the requirements for a comprehensive quality management system specific to the design and manufacture of medical devices, ensuring compliance with international regulations and adherence to the highest standards of reliability and performance.
Marco Ferrari, CEO of Eletech, commented:
“This certification marks a fundamental milestone in ensuring regulatory compliance for the development of complete electromedical devices, further strengthening Eletech’s position in the medical devices market.”
Elemaster wishes to express its sincere appreciation to the Quality Team for their exceptional effort and dedication, which made this achievement possible.