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.
Our Approach
What We Do
Design control governance
A design and development procedure, plan and review structure proportionate to the product and the company, aligned with ISO 13485 §7.3 and FDA QMSR.
Technical Documentation
Documentation that is complete, traceable and navigable: user needs, design inputs and outputs, verification and validation, risk management and design changes, with the traceability between them maintained as the product evolves.
Design reviews
Planning and chairing formal design reviews at the right gates, with the right people, producing decisions and actions rather than minutes. Our team has chaired ISO 13485 §7.3 design reviews with industrial collaborators as well as internal teams.
Risk management — ISO 14971
Risk management plans, hazard analysis and risk controls integrated with design verification, so that the risk file drives the design rather than being written after it.
Design transfer
Managing the move from development into manufacturing — specifications, process validation, labelling, IFU and the handover to contract manufacturers — so that the product made is the product that was verified.
Design control for external development
Oversight of design activities carried out by partners: agreed deliverables, review points and documentation standards, so the DHF you own is complete even when the work was done elsewhere.
Who this is for
Start-ups and research groups moving a diagnostic from feasibility into regulated development for the first time.
Established companies whose design history files need to be brought into order before an audit, a submission or a due-diligence exercise.
Organisations developing products with external partners — CROs, contract developers, platform companies — who need design control to reach across the partnership.
Programmes that have lost momentum and need an experienced chair for design reviews and decisions.
Connected Services
Design control sits inside the quality system and runs through the whole product development programme. Where the wider system or the programme itself needs attention, see Quality Services and Diagnostics Product Development.
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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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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