Wonde Tekolla

Wonde founded CoActiV Medical Device Consulting in 2025 after more than five years of hands‑on FDA regulatory experience. With a background in microbial biotechnology and business management, he brings scientific rigor and business acumen to regulatory affairs.

Wonde has led and contributed to dozens of client projects across pre‑submissions, 510(k)s, De Novos, 513(g) requests, STeP and Breakthrough Designation requests—consistently reducing submission issues and clarifying strategy.

Earlier in his career, he contributed to analytical development, biomanufacturing, and QC method development, and later expanded into QMS development, technical file gap assessments, and global registrations (including WHO prequalification).