info@erayonetim.com
+90 (216) 376 66 21

ERA Yönetim

Medical Device certification, training
and test services under European standarts.


About US

CE Marking

EZU approved representative authority in Turkey
CE marking services in the field of medical devices

CE Marking

Test Services

ERA Conducts all the tests required by EU product legislation.

Services

NEWS AND EVENTS

Our company participated in IDEX 2022, International Dental Equipment and Materials Exhibition. For details News and Events page.

ACCREDITATION CERTIFICATE IS PUBLISHED

Our company has been evaluated by IAS in a wide scope and accredited for 2022 and our Accreditation Certificate has been issued.

Era Yönetim Test ve Belgelendirme Hizmetleri A.Ş.

Our company has giving certification, training and test services for medical device manufacturers under European product Conformity.
Era Yonetim is the only authorized Turkish representative of the EZU organization approved by the EU.

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.

System Certification

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

Training

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

Test Services

ERA conducts all the tests required by EU product legislation for the manufacturers with its partner.

BUSINESSPARTNERS

www.bcmt.com.tr

BCMT Ürün Laboratuarları A.Ş.

www.ezu.cz

EZU - Elektrotechnicky Zkusebni Ustav

www.ntc-apt.com

APT Testing and Research Pvt Ltd

www.udem.com.tr

UDEM Uluslararası Belgelendirme Denetim ve Eğitim Merkezi