KILKENNY · IRELAND · EST. 2018
Quality you can trust.
Specialist medical device quality & regulatory consultancy — ISO 13485, EU MDR, FDA.
18+
years building quality systems
— Why Device Quality
Senior expertise, without the overhead.
Work directly with Mark — senior QA/RA leadership, embedded for as long as you need it.
More about our approach- 18+
Senior, flexible
C-suite QA/RA leadership without a full-time hire. Engaged at the depth — and duration — you actually need.
years building quality systems - 1:1
Direct with Mark
No junior hand-offs, no account managers. The expertise you hire is the expertise that delivers.
Principal contact - 100%
Proven delivery
A track record of getting Class II and III devices through audit, submission, and to market — on time.
Audit success
- 01
Medical Device Quality & Regulatory Consultant
QMS development, FDA submissions, CE marking, ISO 13485, risk management and post-market surveillance.
- 02
Management Representative & PRRC
Outsourced Management Representative and Person Responsible for Regulatory Compliance under ISO 13485 and EU MDR.
- 03
Fractional QA/RA Executive
Senior quality and regulatory leadership embedded into your team on a flexible, part-time basis.
— Client feedback
In their words
We brought Mark Kelleher in to support our FDA inspection preparation and he delivered exactly what we needed. He got up to speed fast, was straight with us about where the gaps were, and the advice he gave our team put us in an excellent position.
Mark also helped us navigate our eQMS selection. He cut through the noise, focused us on what actually mattered from a compliance, implementation and cost perspective.
Practical, experienced, no-nonsense. We'd go back to Mark without hesitation.
Mark led our QMSR remediation project using a practical, hands-on approach which was exactly what we needed. He emphasised the importance of buy-in from our team who were fully engaged throughout the project.
The remediated QMS was scaled appropriately to the business structure and gives us an excellent foundation for ongoing compliance with regulatory requirements.
Nationwide reach
Trusted by medical device teams across Ireland.
From Galway and Dublin to Cork, Tipperary and Wexford, we support medical device companies throughout Ireland — all while remaining rooted in Kilkenny.
Contact
Let's talk.
Send a short message and we'll respond within one business day.