SERVİCES

CE Marking

EZU with the number 1014, the only EU approved representative authority in Turkey since 2005, carries out conformity assessment (CE marking) services in the field of medical devices.

CE Marking

System Certification

Since 2005 ERA Yönetim is certifying Medical companies according to ISO 13485 (Quality management System for Medical devices).

System Certification

Training

With specialized and well trained auditors and trainees, Era Yönetim is giving following trainings for Medical Device manufacturers.

Trainings

Test Services

ERA conducts all the tests required by EU product legislation for the manufacturers with its partner. Biomechanical tests, Biocompatibility tests, Validation tests, etc.

Test Services