Naveed A

Senior Regulatory Affairs & QMS Consultant | EU MDR, FDA 510(k), ISO 13485

MDR Advisory • Freelance

Oct 2022 - Present • 3 yrs 7 mos

Regulatory Affairs & QMS Consultant with 25+ years of experience supporting clients across medical devices, IVDs, cosmetics, food, and pharmaceuticals. Specialized in EU MDR, UKCA, and FDA compliance, including 510(k) submissions and FDA Establishment Registration. Key achievements include preparation of Technical Documentation/Technical Files, development of ISO 13485 QMS documentation, and execution of risk management (ISO 14971), CER, and IFU compliance. Conducted gap assessments, internal audits, and provided practical regulatory strategies to ensure audit readiness and efficient market access. Focused on delivering clear, compliant, and actionable solutions tailored to client needs.