What people are saying.

  • “Our company has had the pleasure of working with FPDX Consulting over a number of projects and we couldn't be more satisfied with our experience.  We have a small team, with little regulatory experience, and FPDX Consulting has helped us to attain ISO 13485 AND ISO 15189 within a short time. We would highly recommend FPDX Consulting to other companies needing regulatory help with medical devices.  Her expertise, professionalism, and dedication are first class.”

    — Professor Sheena E. M. Lewis. Former CEO, ExamenLab Ltd.

  • “FPDX Consulting has deep knowledge and practical experience in the design, development, regulation and commercialisation of complex in vitro molecular diagnostic and prognostic products.  Fionnuala’s foundation expertise in bioinformatics, overlaid with a deep and state of the art understanding of quality management and regulatory requirements in UK/EU and US settings, is invaluable for any enterprise embarking on clinical diagnostic and prognostic test development. I feel she is second to none as a guide and consultant in the journey of bringing new diagnostic and prognostic technologies to benefit patients”

    — Andrew Sandham. Chairman, Predictimmune Ltd.

  • “Fionnuala supported the set up of our bioinformatics function in Achilles Therapeutics early days. She became a part of the team and that was central to the impact and success she was able to bring. I highly recommend Fionnuala to those requiring support building a strong foundation for compliant bioinformatics and data pipeline success.”

    — Iraj Ali. CEO, Achilles Therapeutics Ltd.

  • "Fionnuala's extensive knowledge of software development, quality management, and regulatory affairs provides a holistic understanding to provide integrated/aligned solutions, whether leading projects or providing support to internal teams. She brings a perfect balance of pragmatism and clarity, ensuring that legal and practical requirements are addressed without compromise.   I wholeheartedly recommend FPDx Consulting to anyone seeking support for software development or Quality implementation within a regulated framework. Fionnuala's professionalism and dedication will undoubtedly lead to significant contributions to your product development journey"

    — Alan Schafer. Former CTO, Inivata Ltd.

  • "At Healx we apply AI to discover and advance treatments for Rare Disease. Quality Assurance and Compliance are critical components of our workflows. We are thankful to Fionnuala for providing us with advice and materials that kick started the establishment of our preclinical quality processes early on."

    — Ian Roberts. Director of Therapeutic Technology, Healx Ltd.