Metehan Agaca

I have previously worked for small and mid-sized medical device companies in Product Development and Quality and Regulatory Affairs roles. Throughout my career I have contributed design activities of various products such as implants and cardiac and vascular products. Later, I have worked with Micro-Electronical-Mechanical Systems (MEMS) for medical devices and then made the move to the quality and regulatory field.

I am qualified as a medical device assessor and auditor for a Notified Body, where I gained practical experience in the following topics: Quality Management Systems (QMS) (ISO 13485), Risk Management (ISO 14971), Software (IEC 62304), Usability (ISO 62344), Information Security (ISO 27001) and on Management Review and Clinical Evaluation.
At Starodub, I use my experience to provide clients with the best and most efficient science-based support. Furthermore, I am proud to be a part of the multidisciplinary team contributing to overall positive impact at our customers.

Additionally, my skills include building a QMS, including drafting the procedures from scratch in my last position, creation of a ‘culture of quality’ and performing relevant trainings including stakeholder management for the whole organization.