Independent IVD consultancy

Europe, North America & Asia

Senior IVD expertise, hands on

Dolmen Diagnostics is an independent consultancy for in vitro diagnostic and medical device companies. We help teams take diagnostic products through development, quality systems and regulatory approval — with the experience of having done it ourselves.

Our Experience

Our Experience

Our Experience

Experience that has carried products to market

Founded in 2023 , we provide strategic advice, hands-on delivery and interim leadership to pharmaceutical, biotechnology and diagnostics organisations across Europe, North America and Asia.

The approach is practical. Complex technical, quality and regulatory challenges are turned into clear action plans that keep development moving, improve compliance and support commercial delivery.

A record of delivery, not just advice

Programmes supporting WHO-prequalified and IVDR-approved diagnostic products, from assay development through to launch.

30+

Diagnostics team built and led, achieving ISO 13485 certification

£3m+

Development portfolios managed

CLIA · CAP

Accredited laboratories established and managed

A record of delivery, not just advice

Programmes supporting WHO-prequalified and IVDR-approved diagnostic products, from assay development through to launch.

30+

Diagnostics team built and led, achieving ISO 13485 certification

£3m+

Development portfolios managed

CLIA · CAP

Accredited laboratories established and managed

A record of delivery, not just advice

Programmes supporting WHO-prequalified and IVDR-approved diagnostic products, from assay development through to launch.

30+

Diagnostics team built and led, achieving ISO 13485 certification

£3m+

Development portfolios managed

CLIA · CAP

Accredited laboratories established and managed

Testimonials

Our Clients

Ciaran quickly built strong relationships across our teams, enabling him to rapidly understand our operations and conduct a remarkably thorough quality assessment in a very short timeframe. What I appreciated most was his pragmatic approach, balancing quality improvements with the realities of a growing life sciences business and ensuring recommendations were both impactful and sustainable.
Raphael Werding
Head of Life Sciences and Site Lead, Hologic-Liege

Frequently Asked Questions

FAQs

What does Dolmen Diagnostics do?

We provide consultancy to companies developing in vitro diagnostics and medical devices, covering IVDR compliance, ISO 13485 quality systems, design control and diagnostic technical guidance on product development. Engagements range from a focused gap assessment to hands-on programme delivery and interim leadership.

Who do you work with?

Where are you based, and do you work on site?

How does an engagement work?

Get in touch

Let's talk about your project

Whether you need a readiness assessment, hands-on support or interim leadership, get in touch and we will discuss how we can help

Get in touch

Let's talk about your project

Whether you need a readiness assessment, hands-on support or interim leadership, get in touch and we will discuss how we can help

Get in touch

Let's talk about your project

Whether you need a readiness assessment, hands-on support or interim leadership, get in touch and we will discuss how we can help

Independent in vitro diagnostic consultancy

Europe, North America & Asia

© Dolmen Diagnostics 2026. All rights reserved.

Independent in vitro diagnostic consultancy

Europe, North America & Asia

© Dolmen Diagnostics 2026. All rights reserved.

Independent in vitro diagnostic consultancy

Europe, North America & Asia

© Dolmen Diagnostics 2026. All rights reserved.