System certification
Management system certification as per international standards.
Product certification IVDR
Conformity assessment of in vitro diagnostic medical devices as per Regulation (EU) 2017/746.
Product certification MDR
Conformity assessment of medical devices as per Regulation (EU) 2017/745.
Trainings
Wide range of trainings and seminars from area of our activities.
Other
Certification of the Importer / Distributor of medical devices, Energy audit, Legislative audit, ...
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3EC International a.s. is dynamic international certification body which is currently accredited by SNAS for several standards in the area of management system certification and Authorized and Notified Body for conformity assessment of medical devices and in vitro medical devices as per European Regulations.
From 28 May 2026, the use of the first four modules of the European database on medical devices, EUDAMED, becomes…
The second edition of the standard ISO 37001:2025 was published in March 2025, replacing the previous edition, ISO 37001:2016 (ISO 37001:2016/Amd 01/2024).…
