MEDCER is founded in 2015 by Mehmet Fatih Örmeci. MEDCER is accredited on ISO 13485 as a certification body from 2016 to 2020. MEDCER continues to activities on ISO 13485:2016 certification as 3rd party certification body together with partners. In addition to this, MEDCER provide supplier audits and internal audits in according to ISO 13486, 2017/MDR and 21 CFR 820 for their clients.
MEDCER also provides consultancy services to clients for technical documentation on legal requirements and quality management systems. These covers design dossier and technical file preparation for EU legal requirements and 510(k) submission file preparation for US legal requirements.
MEDCER also provides training for medical device industry including manufacturers, certification body and competent authorities on several individual subjects. Most frequent training subjects are ISO 13485 QMS Requirements, ISO 14971 Risk Management, CE Marking, Sterilization and Process Validation trainings.
MEDCER also provide testing services in particular biomechanical testing and finite element analyzes. These services are provided to clients as an acredited and non-acredited upon request.
MEDCER also supporting medical device industry for post market surveillance activities and clinical evaluation consultancy.