Frequently asked questions
Faqs
General
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About
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Diagnostics Product Development
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Quality Systems for Diagnostics
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Design Control
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IVDR
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General
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.
Who do you work with?
Where are you based, and do you work on site?
How does an engagement work?
About
Can you take on an interim role?
Yes. Ciarán has held Head of Diagnostics, Head of Product Development and Head of Assay Development roles and can step into Quality, Diagnostics or Product Development leadership for a defined period. See the service pages for the typical shape of these engagements.
Do you work with start-ups as well as large companies?
What types of diagnostic products have you worked on?
Is Dolmen Diagnostics a one-person consultancy?
Working with others
Diagnostics Product Development
What kinds of diagnostic technology have you developed?
Molecular diagnostics including PCR and next-generation sequencing, immunodiagnostics and rapid lateral-flow tests, companion diagnostics in oncology, cardiac biomarker assays and infectious disease tests including TB and syphilis. Platform experience includes laboratory instruments, point-of-care systems and companion software.
Our programme has stalled. What would you do first?
Can you help us choose and manage a contract manufacturer?
Do you design clinical performance studies?
Can you lead our development team on an interim basis?
Quality Systems for Diagnostics
How long does it take to build an ISO 13485 quality system?
For a small company starting from little, a proportionate system can typically be designed and implemented within six to nine months, with certification following once there is evidence the system is in use. Remediation of an existing system is usually faster. The timeline depends most on how quickly the organisation can adopt the processes.
Can you prepare us for a notified body audit or FDA inspection?
Do you cover laboratory accreditation as well as manufacturing quality?
What does interim Quality leadership involve?
Our suppliers and contract manufacturers are the weak point. Can you help?
Design Control
Can you chair our design reviews?
Yes. An experienced, independent chair keeps reviews focused on the decisions that matter and ensures they are properly recorded. This can be a standalone engagement or part of wider programme support.
When should design control start?
We already have a partially complete DHF. Can it be rescued?
How does design control relate to ISO 14971 risk management?
Our development partner does most of the design work. Who owns design control?
IVDR
Does IVDR apply to our product?
If you place an in vitro diagnostic on the EU market, yes — including products previously self-declared under the IVD Directive, software that meets the IVD definition, and many products that were considered low risk under the old rules. The first task is classification under the IVDR rules, which determines the conformity assessment route and how much notified body involvement you need.