Ajith is a MedTech quality and regulatory leader with extensive experience across global medical device frameworks, including MDSAP, ISO 13485, EU MDR/IVDR, and UK MDR. His background spans clinical engineering, device lifecycle management, multi‑jurisdictional audits, and global QMS leadership, combining hands‑on technical expertise with strategic regulatory insight. At BSI, Ajith supports accreditation and designation for major regulatory schemes through report approvals, competence development, and cross‑regional collaboration. He leads process improvement initiatives that enhance audit quality, manage risk, and optimise operational delivery. A Registered Clinical Technologist, Ajith is passionate about capability building, impactful training, and simplifying complex regulatory expectations to support safe, effective healthcare technologies worldwide.
