SME Profile

Maria E. Donawa

  • Nearly thirty years’ regulatory experience, including six years with FDA CDRH
  • President of Donawa Lifescience Consulting Srl
  • Former quality systems lead auditor for an EU Notified Body
  • Member of ISO TC 210 Working Group 1 and ISO TC 194 Working Group 4
  • Regulatory affairs columnist for Medical Device Technology magazine
  • Regular speaker at US and European conferences
  • Instructor in areas of US and European device regulatory and quality system requirements
  • US pharmacy and medical degrees, post-doctoral specialty in clinical and anatomical pathology, licensed to practice medicine in the US