Osman Dursun

(Founder)

Osman is a graduate of Bogazici University Physics Department and has over 20 years experience in medical devices. Since 2003 he has been working as a partner and management system expert at ConsulTeam Medical.

Osman takes part in consultancy, training and second party audit activities in ConsulTeam Medical, with a focus on establishing effective quality management systems for his clients.

He has a wide expertise on legal requirements covering the harmonization processes with the EU legislation including the new MDR (EU 2017/745) and IVDR (EU 2017/746). Since 15 years, he achieved effective implementation and customization of management systems in many projects.

In addition to CE Marking, Osman also provides consultancy services on various product and system certification, including the US FDA 510K and MDSAP.

Osman is qualified as a “Lead Auditor” for ISO 13485 and MDD. He works as an external resource auditor for one of the leading European notified body.

osman@13485.info