Esra TATLI

Esra Tatli is an experienced Quality Assurance and Regulatory Affairs professional with over 12 years in the medical device industry, specializing in standards such as ISO 13485 and EU MDR (2017/745). Currently serving as a Quality Manager at InfoDif, Esra leads initiatives focused on process maturity models and compliance with international quality standards. Esra has previously held roles including Quality Manager at Medbar Medical Supplies and Quality Assurance Manager at Pharmamed Medical Devices, where they managed ISO standards and CE certification. With advanced degrees in Biomedical Technologies and Business Administration, Esra has also authored two influential books on ISO 13485 and EU MDR, recognized as the first of their kind in Turkey.