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.
Our Approach
What We Do
IVDR readiness assessment
A structured review of your products, technical documentation and quality system against IVDR requirements, giving you a clear picture of classification, conformity assessment route, gaps and priorities.
Remediation and implementation
Closing the gaps: technical documentation, performance evaluation planning, post-market surveillance, and the ISO 13485 quality system elements that IVDR depends on. We plan the work and, where needed, do it with your team.
Regulatory strategy
The right route for the product and the business — classification, notified body selection and interaction, the sequence of markets, and how the evidence generated for one submission can serve the next.
Submission support — IVDR, FDA, WHO-PQ
Preparation, review and coordination of submissions across regions, drawing on programme experience with products that have gone through IVDR approval and WHO Prequalification.
Technical due diligence
Independent assessment of a diagnostic technology, product or company for investment, licensing or acquisition: regulatory status, technical maturity, quality system and the realistic path to market.
Who this is for
Manufacturers with legacy CE-marked products that must transition to IVDR before the relevant deadlines.
Developers bringing a new IVD to the market for the first time.
Companies extending a product to other markets and needing a coordinated strategy across IVDR, FDA and WHO Prequalification.
Investors and acquirers who need an independent view of a diagnostic technology or company’s regulatory position.
How an engagement runs
Most IVDR work starts with an assessment of two to six weeks that produces a written gap report and a prioritised plan. From there, clients choose to implement the plan themselves with periodic review, to have us deliver defined parts of it, or to have us lead the programme through to submission.
Each option is scoped and priced in advance. IVDR compliance rests on the quality system and on design control.
Where those need attention we address them as part of the same programme.
Related Services
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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