Hafsa I

@hafsa1991

Trust me and hire me!

Pakistan

Engels, Punjabi, Urdu

Sommige informatie wordt in het Engels weergegeven.

Over mij

Medical Device Production & Regulatory Consultant with 7+ years of experience in device development, technology transfer, and regulatory compliance for both medical devices and SaMD. Skilled in preparing and reviewing Technical Files, Design Files, Biological Evaluation Reports (ISO 10993), Clinical Evaluation Reports (MDR), Risk Assessments (ISO 14971), and SOPs. Experienced in ISO 13485 QMS implementation, audit readiness, and regulatory submissions across EU MDR, FDA, SFDA, and other markets. Strong background in shelf-life studies, manufacturing licensing and SaMD compliance... Lees meer

Skills