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.
Our Approach
What We Do
ISO 13485 quality management systems
Building a proportionate QMS from the ground up, or remediating one that exists to comply with ISO13485 to ensure compliance with other key standards such as ISO14971 and if software is part of a device IEC62304. Also, where relevant, FDA 21 CFR Part 820 / QMSR — with procedures people will follow because they reflect the work.
Gap assessments
Independent assessment of your organisation against ISO 13485, ISO 17025, FDA QMSR or IVDR quality system requirements, producing a prioritised improvement roadmap for senior leadership.
CAPA, change control and document control
Getting the core processes right: corrective and preventive action that resolves root causes, change control that keeps design and regulatory status aligned, and document control that works for scientists as well as auditors.
Supplier qualification and external partner oversight
Qualification, agreements and ongoing quality oversight of contract developers, contract manufacturers and critical suppliers, so that outsourced work meets the standard your certification depends on.
Audit and inspection readiness
Internal audits, mock inspections, audit-response coaching and remediation planning ahead of notified body, FDA, MHRA, UKAS or accreditation body visits — and support during them.
Laboratory accreditation
Establishing and managing laboratory quality systems for CLIA certification, CAP accreditation and ISO 17025, from initial set-up through to routine operation.
Interim Quality Leadership
Our team have experience of acting as a Quality Manager or Head of Quality for a defined period — holding the management review, owning the system and representing quality to auditors and the board while you recruit.
Who this is for
Companies building a quality management system compliant with standards required for diagnostic product development.
Organisations whose system has grown unwieldy, failed an audit or no longer matches how the business actually works.
Laboratories preparing for ISO 17025, ISO13485, CLIA or CAP accreditation, or moving from research to clinical service.
Manufacturers relying on contract developers, manufacturers and suppliers who need robust qualification and oversight.
Businesses without a Quality leader in post who need one now.
Connected Services
Validated quality systems, regulatory compliance and design control depend on each other.
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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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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