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Hafsa I
@hafsa1991
Trust me and hire me!
Pakistán
Inglés, Punjabí, Urdu
Sobre mí
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
Habilidades
Hafsa I
desconectado •
Revisa mis servicios
Escritura técnica
I will write regulatory documents and compliance reports for med devices
Escritura técnica
I will prepare sfda technical file, mds req 01 submission and device documentati
