Case studies · Selected engagements
Work that moves regulators, not just paper.
A look at how Device Quality Ltd. partners with medical device companies in Ireland — from greenfield QMS builds in Galway to FDA QMSR remediation for established SMEs.
A newly incorporated contract design and manufacturing organisation in the Galway medical device cluster engaged us pre-operations to design, document and implement a fully compliant Quality Management System — before their first client programme landed.
3
regulatory frameworks aligned in one QMS
IQ · OQ · PQ
clean room qualification delivered
100%
staff trained & competency assessed
Phase 01
QMS design & documentation
Regulatory scoping across ISO 13485, QMSR and EU MDR mapped overlap and divergence into a single integrated architecture. We authored the Quality Manual, SOPs covering every QMS process, and operational work instructions — all developed alongside the client's SMEs so procedures were practical and audit-ready.
Phase 02
Clean room establishment & qualification
We coordinated specialist clean room design and validation contractors, providing quality oversight across IQ, OQ and PQ. Environmental monitoring, gowning protocols and access controls were documented inside the QMS, with all qualification data reviewed and approved through the quality system.
Phase 03
Staff training & competency
A structured programme covered QMS awareness, document control, good documentation practice, clean room behaviour and process-specific work instructions. Training records and competency assessments provide the objective evidence ISO 13485 and EU MDR auditors scrutinise.
Phase 04
Notified Body engagement & audit support
We managed the Notified Body relationship throughout certification — preparing the submission package, coordinating audits, hosting remote document review and onsite sessions in Galway, and drafting structured CAPA responses for non-conformances.
OUTCOME
Clean room qualified and operational. Staff trained and competency-assessed. A robust, scalable QMS fully aligned to EU MDR and 21 CFR 820 QMSR — and a strong regulatory foundation from day one of operation.
A growing Irish medical device manufacturer with an established ISO 13485-aligned QMS engaged us to close significant gaps against the FDA's updated Quality Management System Regulation — the most substantial revision to FDA device quality requirements in decades. US market access was at risk; structured remediation was business-critical.
12 weeks
phased implementation plan
1×
each document touched — no rework
Full
documented QMSR compliance achieved
Phase 01
Gap analysis
A structured comparison against every subpart of the updated 21 CFR 820 QMSR — across management responsibility, design controls, purchasing, production, CAPA and complaint handling. The output was a scored gap register, with each gap translated into a discrete, prioritised remediation action grouped by impacted QMS system so every document was only touched once.
Phase 02
Detailed project plan
A comprehensive twelve-week phased plan with milestones, deliverable deadlines, resource assignments and interdependency mapping to prevent bottlenecks. CAPAs and nonconformances were used to assess product- and compliance-related risk. Steering committee reviews closed each phase to keep governance tight.
Phase 03
Phased implementation
Revised policies and procedures were drafted by our team and reviewed iteratively with the client before formal approval. Every document was version-controlled and released through the existing document control system, with CAPA and nonconformance processes tracking outstanding actions to completion.
OUTCOME
Full documented compliance with 21 CFR 820 QMSR delivered on plan. Beyond compliance, the engagement strengthened the client's internal quality culture and positioned the company for confident growth in the US market.