Naveed A

Medical Device Regulatory and QMS Consultant

Consultants • Freelance

Nov 2022 - Present • 3 yrs 10 mos

Provide medical device regulatory and QMS consulting services to medical device and IVD companies, supporting regulatory compliance, quality systems, and technical documentation. Experienced in FDA registration and listing, 510(k), EU MDR, UKCA, ISO 13485, ISO 14971, technical documentation, risk management, CER, IFU, SOPs, validation, CAPA, SCAR, audits, and regulatory submissions. Deliver practical, accurate, and audit-ready documentation tailored to client and product requirements.