
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.
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.
Diagnostics Product Development
Getting from a promising assay to a product that is manufactured, validated and approved takes more than good science. Dolmen Diagnostics provides the development strategy, technical leadership and programme governance
Diagnostics Product Development
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Quality systems for diagnostics
Dolmen Diagnostics builds and repairs quality management systems for IVD and medical device companies, prepares them for certification, audits and inspections, and provides Quality leadership when the role is empty.
Quality systems for diagnostics
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Design Control
Design control is the discipline that turns an assay into a product a regulator can trust. Dolmen Diagnostics sets up design control that fits the organisation, brings existing programmes under control, and provides the independent oversight that design history files need.
Design Control
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Regulatory Strategy & Compliance
Regulation (EU) 2017/746 changed the rules for in vitro diagnostics in Europe. Most products now need a notified body, a performance evaluation that stands up to scrutiny, and a quality system that supports both. Dolmen Diagnostics helps companies understand exactly where they stand.
Regulatory Strategy & Compliance
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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.
