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