Services
How we can help
↘ What we offer
Dolmen Diagnostics works across the four disciplines that decide whether a diagnostic product reaches the market and stays there: regulatory compliance, design control, the quality system and product development itself. Each can be engaged on its own; in practice they are connected, and we work across them
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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
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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.
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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.
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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.
How we engage
Three ways to work together
Strategy
Assessment
A defined piece of analysis with a written output: a gap assessment, a regulatory strategy, a due-diligence report or a roadmap. Fixed scope and fee, usually two to six weeks.
Hands-on
Senior Insight
Hands-on work inside your programme for an agreed period — building the system, running the reviews, managing the studies and submissions with your team.