Esra TATLI

We provide professional consulting services for organizations involved in the life cycle of medical devices. Within the scope of our activities, we provide consultancy services on the establishment of quality management system in accordance with ISO13485 standard,preparation for control and certification inspections, completion of preparations for CE certification inspections of medical devices in accordance with European Union medical device legislation,trainings and infrastructure and process validations.

• Head of quality department which includes maintaining quality management system, regulatory affairs, CE certification and quality control. o Control and maintain ISO 13485 quality management system, transitioning to 2016 revision of the standard, quality documentation o Control/management of technical dossiers • Working together with engineering department on validations of special processes (EtO sterilization, packaging, clean room infrastructure)

• Performing ISO 13485 and ISO 9001 certification and follow-up audits of companies who works in medical device sector • Checking technical dossiers of customers

- Establishment and maintaining ISO 13485 QMS for Medical Devices and ISO 9001 Quality Management System - Preperation of technical and design dossiers (classification, technical drawings on AutoCAD, risk management (ISO 14971), clinical data evaluation, biocompatibility data evaluation (ISO 10993) ) and CE certification of medical devices acc. to MDD 93/42/EEC

Establishing and performing an integrated Quality Management System including ISO 9001, ISO 22000, ISO 14001 and OHSAS18001 - Quality documentation - Risk management (food related, occupational and enviromental) - Internal audits - Supplier audits - Follow-up customer complaints - Follow-up of corrective and preventive actions

MSc Dissertation: CHANGES INTRODUCED BY THE EUROPEAN MEDICAL DEVICE REGULATION WITH NUMBER 2017/745 AND MEASUREMENT OF ADAPTATION LEVEL OF MEDICAL DEVICE MANUFACTURER ORGANIZATIONS IN TURKEY

MSc Dissertation: "An Application on Differences of ISO 13485 Quality Management System for Medical Devices from ISO 9001 Quality Management System"