Ifrah Ansari

I am a Regulatory Affairs and Quality Management System specialist with hands-on experience developing and implementing ISO 13485 and 21 CFR Part 820 compliant systems for Class I–III medical devices, and preparing global submissions (CE, FDA, SFDA, TGA). I deliver end-to-end technical documentation, risk management, clinical and biological evaluations, and post-market surveillance to ensure regulatory compliance and audit readiness.

I have supported device manufacturers across Europe, the Middle East, and North America, authored Design History Files, Technical Files/Design Dossiers, and led QMS implementations that achieved ISO 13485 certification and regulatory registrations. I prioritize precision, cross-functional collaboration, and continual improvement to bring safe, compliant devices to market.