Πέμπτη 13 Νοεμβρίου 2025
Press Releases

EUROCERT Expands Its Accreditation Portfolio – Certification of Medical Devices for Healthcare Units Now Under ISO 13485

EUROCERT proudly announces its accreditation by the Hellenic Accreditation System (E.SY.D.) in accordance with the International Standard ISO 13485, which defines the requirements for Quality Management Systems in the field of medical devices.

This extensive accreditation scope positions EUROCERT among the leading certification bodies in Europe within this domain, providing clients with comprehensive, reliable, and internationally recognized assessment services.

The new certification service addresses manufacturers and distributors of medical devices, as well as companies engaged in installation, maintenance, and technical support of such products.

Certification in these sectors has now evolved into a key prerequisite for business development and partnership agreements, as it adds significant value and strengthens a company’s credibility and market reputation.

Moreover, for suppliers to public healthcare units, certification under ISO 13485 constitutes a legal requirement, alongside other international standards such as ISO 9001, ISO 37001, ISO 27001, and Ministerial Decision 4822 — all of which EUROCERT already delivers with consistency and integrity.

Through this new accreditation, EUROCERT further enhances its position as an independent and internationally acknowledged certification body, leveraging the expertise and experience of its auditing team to promote quality and safety in the field of medical devices.