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Áine Mary Duffy, BSc (Hons), PhD

Manager, Regulatory & Medical Writing Services

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Áine Duffy has been a medical device consultant for over 5 years, gaining experience in several therapeutic areas, including vascular, cardiovascular and gastrointestinal. She has aided clients with the transition of clinical evaluations to the Medical Device Regulation (MDR) and helped address non-conformities issued by Notified Bodies. She has also worked with physicians to develop manuscripts for publication in peer-reviewed journals.

Following a career in academia, which included an adjunct professor role at New York University, Áine joined NAMSA’s Syntactx in 2017 to apply her research and problem-solving skills in medical writing. Áine has a broad scientific background, with post-graduate experience in basic research and a PhD in neuroscience.


  • Managing project timelines and resourcing for regulatory and medical writing projects
  • Providing mentorship and leadership to the regulatory and medical writing team
  • Developing Clinical Evaluation Plans and Reports (MEDDEV 2.7.1/rev. 4 and EU MDR)
  • Performing systematic literature reviews and analysis of data extracted from the literature for regulatory submissions
  • Preparing manuscripts, protocols, study reports and other deliverables in conjunction with clinical teams
  • Working with the internal regulatory strategy team and Sponsors on submissions to the U.S. Food and Drug Administration (FDA)
  • Assisting Sponsors with responses to queries from regulatory bodies
  • Development of post-market documentation (PSUR, PMCF Reports, PMS and PMCF plans


  • Worked with several Sponsors on transitioning Clinical Evaluations to meet MDR
  • Successfully assisted Sponsors with responses to Notified Bodies
  • Drafted a clinical manuscript that has been recently published in a peer-reviewed journal