About Dolmen Diagnostics
Experience that diagnostic programmes need
↘ Who we are
Dolmen Diagnostics is an independent consultancy for in vitro diagnostics and medical devices, founded in 2023 and based in Belfast, Northern Ireland. We provide the senior technical, quality and regulatory expertise that diagnostic programmes need and that most organisations cannot keep permanently on the payroll.
What we stand for
Built to carry the regulatory load
The name comes from Ballykeel Dolmen in County Armagh, a structure that has stood for thousands of years because its weight is well distributed. It is a fair description of what we do: take the technical, quality and regulatory burden of a diagnostics programme and put a structure under it that holds.
Three things shape every engagement
Knowledgeable
More than twenty years in diagnostics, spanning clinical laboratories, assay development, ISO 13485 quality systems, IVDR, FDA and WHO Prequalification.
Experienced
Leadership roles at LifeArc, Biofidelity and Osler Diagnostics, and consulting engagements with Abbott, Hologic, Alexion (AstraZeneca) and Eurofins. The advice comes from having delivered the work, not observed it.
Pragmatic
Regulation is dense; projects still have to move. We translate requirements into clear actions.
Experience
Our Experience
Ciarán Fulton
Director & Principal Consultant
I began my career at the laboratory bench and have spent more than 20 years working across the science, product development, quality systems and regulatory disciplines required to turn diagnostic assays into commercially viable products. I founded Dolmen Diagnostics in 2023 to bring this experience directly to pharmaceutical, biotechnology, and diagnostics organisations, providing strategic advice, technical leadership, and hands-on support across product development, IVDR, quality, and regulatory programmes.
At LifeArc, I built the Centre for Diagnostics Development from two scientists in 2014 to a multidisciplinary team of more than 30 by 2021, establishing an ISO 13485:2016-certified organisation in the process. I directed a £3 million+ TB disease monitoring assay programme, overseeing development from preclinical and clinical activities through manufacturing, packaging, labelling and regulatory requirements.
I owned the Design History File structure, chaired formal ISO 13485 design reviews with industrial partner Biocartis, oversaw ISO 14971 risk management and served periodically as acting Quality Manager. I also helped secure LifeArc’s first diagnostics licensing agreement with Bruker within 18 months of project initiation.
Since then, I have held senior product development and consulting roles across the US, Europe and Asia. At Biofidelity, I led development of the ASPYRE product range, including commercial kit manufacturing, supplier onboarding, and helping establish a CLIA-certified laboratory in North Carolina. At Osler Diagnostics, I led more than 30 scientists developing and integrating diagnostic assays for the Origin platform, with a particular focus on cardiac biomarkers.
My consulting experience includes 18 months as Global R&D Technical Lead for Abbott Rapid Diagnostics, supporting two Abbott Diagnostics Japan product launches through validation, verification and pre-launch readiness, leading to successful WHO Prequalification and IVDR approvals. I have also conducted an ISO 17025 gap assessment and improvement programme for Hologic’s Diagenode business, developed regulatory and quality strategy for Eurofins’ EU Reference Laboratory application, and most recently established a quality framework for Alexion’s externally developed IVDs used in clinical trials and companion diagnostic programmes.
Earlier in my career, nine years at Almac Diagnostic Services gave me a strong operational foundation in clinical laboratory and technical development. I established CLIA- and CAP- accredited laboratory operations, introduced next-generation sequencing using the Illumina platform, managed ISO 17025 activities and supported diagnostic product development.
I hold a PhD in Molecular Biology and a BSc (Hons) in Applied Microbiology from Queen’s University Belfast. My experience spans the full diagnostic product lifecycle, from assay development and design control through quality systems, regulatory strategy, verification and validation, manufacturing and commercialisation.
Credentials
Regulatory and quality
IVDR (EU 2017/746) · ISO 13485 · FDA 21 CFR Part 820 / QMSR · ISO 14971 · ISO 17025 · CLIA · CAP · WHO Prequalification
Product Development
assay development · verification and validation · clinical performance studies · design transfer · companion diagnostics · molecular diagnostics · immunodiagnostics · product lifecycle management
Leadership
Head of Diagnostics, LifeArc · Head of Product Development, Biofidelity · Head of Assay Development, Osler Diagnostics · Global R&D Technical Lead, Abbott Rapid Diagnostics
Education
PhD Molecular Biology and BSc (Hons) Applied Microbiology, Queen’s University Belfast
30+
Diagnostics team built and led, achieving ISO 13485 certification
£3m+
Development portfolios managed
CLIA · CAP
Accredited laboratories established and managed
How we work
Three principles
Strategic Advisory
Independent assessment and direction: gap analyses, regulatory strategy, technical due diligence and roadmaps that senior teams can act on.
Hands-on Delivery
Doing the work alongside your team — building the quality system, running the design reviews, managing the verification programme, preparing the submission.
Interim Leadership
Stepping into Quality, Diagnostics or Product Development leadership roles for a defined period, with the authority and accountability the role needs.
Every engagement is scoped in writing, with clear deliverables and either a fixed fee or a day rate. Confidentiality is standard; we are happy to sign your NDA before any detail is shared.