End-to-end expert consulting for your medical device processes

ESAYTECH provides expert consulting services for medical device manufacturers in MDR 2017/745 technical file preparation, sterilization validation, PMCF planning and reporting, and FDA company and product registration. Our team has 15+ years of experience in ISO 13485 quality management, clinical evaluation, and risk management.

Under validation services, we manage packaging and stability validation, manufacturing process validation, software validation, PMS planning and reporting, PSUR reporting, and trend reporting. We have international experience with BfArM Germany, CDSCO India, Russia, and Saudi FDA approval processes.

We provide single-point services for MDSAP, UCKA approval, and global market access, accelerating your medical device documentation processes and optimizing costs.