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Elaine D. O’Neill, PhD

Senior Medical Writer, IVD

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Elaine has been in the In Vitro Diagnostic (IVD) industry for 9 years, bringing to market numerous CE marked calibrators, quality controls and linearity verifiers. Elaine has been responsible for maintaining technical files for all products ensuring compliance with legislation (ISO 13485:2016, IVDD and IVDR), including risk assessment and risk management of products, and preparation for audits. She is experienced in all stages of the R&D process of IVDs including initiation, feasibility, design lock, verification, validation, design transfer and all documentation associated to enable a product to be released to market.

Prior to joining NAMSA in 2021, Elaine worked for Randox Laboratories in the UK as an R&D Scientist and then as an R&D Team Leader of IVD products, where she was managed up to 20 active projects and 8 staff members at one time. Preceding this, she worked as a Postdoctoral Research Associate at the University College Dublin where she headed a project optimizing a genome wide screen using an automated microscopy and siRNA approach.

Elaine holds a PhD in Pathophysiology from The University of Liverpool (UK) with a focus on aging skeletal muscle and insulin resistance, and a BSc (Hons) in Biomedical Sciences from Newcastle University (UK).


  • Previously headed a team of scientists whose main function is IVDR compliance (primarily clinical evidence based), ensuring all documentation is in place and all quality control products comply to the new IVDR standard
  • Gap analysis of existing Technical Files, determining what is usable for an analytical performance report, creating Performance Evaluation Plans (PEPs) and overseeing and reviewing any data collection required
  • Design and development of numerous CE marked quality controls and the associated paperwork, from start to finish which are now on the market
  • Management of up to 20 research projects at different stages of development at one time
  • Experience in several IVD areas such as Biochemistry, Clinical Chemistry, Coagulation, Oncology, Cardiology, Immunology and Biomarker Discovery
  • Redesign of the research and development documentation following new regulation guidelines to ensure the continued compliance of the company—inclusive of changes in the standard analytical testing for each product following post market surveillance feedback, and how design risk is linked throughout the product development following an external audit


  • Preparation of PEPs and Performance Evaluation Reports (PERs) to support EU IVDR 2017/746 compliance in hematology, oncology and infectious disease devices
  • Literature reviews for oncology and infectious disease panels in Technical File preparation for EU IVDR 2017/746 compliance