Your Trusted Partner in Medical Devices
We are Turkey's leading medical device consulting firm specializing in MDR 2017/745, technical file preparation, and validation.
Solutions That Add Value to Healthcare
At ESAYTECH, we simplify complex regulatory processes in the medical device sector, helping manufacturers bring their products to market faster and with confidence.
15+
Years of Experience
200+
Completed Projects
50+
Global Clients
12+
Countries of Operation
Reliability
We add value to our clients with a transparent, honest, and reliable approach in every project.
Expertise
In-depth technical knowledge and experience in MDR 2017/745, ISO 13485, and validation.
Global Perspective
Experience working with FDA, BfArM, CDSCO, and other international regulatory bodies.
Client Focus
We provide personalized solutions by placing each client's needs at the center.
Professional Support at Every Stage
Our expert team is by your side throughout all regulatory and validation processes in the medical device sector.
MDR 2017/745 Technical File
Comprehensive technical file preparation, clinical evaluation, and PMCF processes for your medical devices.
Sterilization Validation
Full validation services for EO, steam, radiation, and other sterilization methods.
ISO 13485 Quality System
Quality management system implementation, internal audit, and continuous improvement consulting.
Global Market Access
End-to-end support for FDA, BfArM, CDSCO, Russia, and Saudi FDA applications.