Experience

Kiwa Türkiye

• Türkiye
• Executive Offices
• 1 - 100 Employee

• Technical Expert / Auditor

  • Jan 2020 - Present



ERETNA Tıbbi Cihazlar Sanayi Ve Ticari Limited Sirketi

• Türkiye
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Assurance and Regulatory Affairs Consultant

  • Sep 2018 - Nov 2019

  Consultation for following issues in a medical device R&D and manufacturing compay; - Quality Management System setup - Product CE Certification Consultation for following issues in a medical device R&D and manufacturing compay; - Quality Management System setup - Product CE Certification



Trimpeks Healthcare

• Türkiye
• Medical Device
• 1 - 100 Employee

• Quality Assurance and Regulatory Affairs Responsible

  • Oct 2016 - Nov 2019

  • ISO13485 and ISO 9001 Qualtiy Management System operation • Technical file preparation according to 93/42/EEC and 98/79/EEC • Ministry of Health National Database System (UTS) registration process of Medical Devices • ISO13485 and ISO 9001 Qualtiy Management System operation • Technical file preparation according to 93/42/EEC and 98/79/EEC • Ministry of Health National Database System (UTS) registration process of Medical Devices



Mesa Medikal

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Quality Executive

  • Jun 2010 - Sep 2016

  1. ISO13485 Qualtiy Management System operation 2. Technical file preparation according 93/42/MDD 3. Ministry of Health National Database System (UBB) registration process of following Intensive Care Devices, their accessories and spare parts: • Intensive Care Ventilators • Patient Monitors • Infusion Systems • Neonatal Incubator and Radiant Warmers • Phototherapy Units • ECG • Transport Ventilator 1. ISO13485 Qualtiy Management System operation 2. Technical file preparation according 93/42/MDD 3. Ministry of Health National Database System (UBB) registration process of following Intensive Care Devices, their accessories and spare parts: • Intensive Care Ventilators • Patient Monitors • Infusion Systems • Neonatal Incubator and Radiant Warmers • Phototherapy Units • ECG • Transport Ventilator



LABS Medikal

• Kadıköy İstanbul

• Product Manager

  • Aug 2007 - May 2010

  LUNG IMAGING SYSTEM * Unique Vibration Response Imaging (VRI) Technology - Preparing and Support of Clinical Studies (2 published and 2 ongoing) - Application & follow-up for registration in Turkish Health Legislation - Sales of system (1 unit sold) SLEEP MEDICINE DIAGNOSTICS & THERAPY * Polisomnography & EEG Systems - Preparing and follow-up sales projects (8 units sold) - Preparing of sales materials and technical documents of tender files - Installation and clinical training of systems RESPIRATION THERAPY SYSTEMS * Respiration Therapy Devices & Homecare Ventilator - Installation, training and after sale support DIABETES * Glucometer - Training and after sale support Show less



İNTERAKTİF SİSTEMLER SAN. TİC. A.Ş.

• Bakırköy / İSTANBUL

• Technical Sales Responsible

  • Jun 2004 - Jul 2007

  - Sales, Installation and Technical Support of Following Medical Devices: • Radiotherapy Systems • Surgical Room Equipment (Surgical Tables, Surgical Lights, Electrosurgical Units, Anaesthesia Devices, etc.) • Intensive Care Ventilators • Patient Monitors • Defibrilators • Sterilizators • Disenfection Devices • Turnkey Projects - Sales, Installation and Technical Support of Following Medical Devices: • Radiotherapy Systems • Surgical Room Equipment (Surgical Tables, Surgical Lights, Electrosurgical Units, Anaesthesia Devices, etc.) • Intensive Care Ventilators • Patient Monitors • Defibrilators • Sterilizators • Disenfection Devices • Turnkey Projects



İNTERAKTİF SİSTEMLER SAN. TİC. A.Ş.

• Fındıkzade / İSTANBUL

• Technical Service Technician

  • Jun 1996 - Nov 2003

  - Installation and Technical Support of Following Medical Devices: • Radiotherapy Systems • Surgical Room Equipment (Surgical Tables, Surgical Lights, Electrosurgical Units, Anaesthesia Devices, etc.) • Intensive Care Ventilators • Patient Monitors • Defibrilators • Sterilizators • Disenfection Devices • Turnkey Projects - Installation and Technical Support of Following Medical Devices: • Radiotherapy Systems • Surgical Room Equipment (Surgical Tables, Surgical Lights, Electrosurgical Units, Anaesthesia Devices, etc.) • Intensive Care Ventilators • Patient Monitors • Defibrilators • Sterilizators • Disenfection Devices • Turnkey Projects