At Smart Alfa Teknoloji, I lead quality assurance and regulatory affairs for medical device software and AI-based healthcare solutions. I managed the region's first MDD-to-MDR (2017/745) transition and completed FDA 510(k) clearance for flagship medical software, supporting entry into the US market.
I build quality management systems from scratch and manage product lifecycles from risk analysis through global registration. My work covers ISO 13485, ISO 14971, ISO 14155, IEC 62304, audits, clinical data requirements, and continuous improvement.
Previously, I established QMS and CMMI infrastructure at Ante Grup during COVID and led certification processes for ISO/IEC 27001, ISO 9001, EN 9100, and ISO 14001. At ISLEM GIS, I managed the company’s first CMMI assessment and implemented SPICE frameworks for two subsidiary companies.
I’ve also managed quality processes for sterilisation systems, wound care units, medical consumables, and medical software. I bring more than 10 years of experience, supported by Lean Six Sigma Black Belt training and a practical, compliance-first approach.
