Validex Engineering delivers expert validation & quality consultancy and precision mechanical design services — serving medical device, pharmaceutical, and FMCG manufacturers across Ireland.
Validex Engineering operates across two interconnected specialisms — regulatory-grade Validation & Quality consultancy, and precision Mechanical & Design Engineering. Together they serve the full lifecycle of regulated manufacturing.
We provide end-to-end validation and quality management services aligned to ISO 13485, EU MDR, FDA 21 CFR Part 820, and GMP regulations. From process qualification through to full QMS implementation, our documentation is audit-ready from day one.
Our engineering design capability spans full product and tooling development — from concept through to manufacturing-ready outputs. We operate with industry-standard software and deliver through on-site and remote engagement across Ireland.
Our expertise is concentrated where compliance, precision, and quality are non-negotiable. We understand the regulatory language, the production pressures, and the documentation expectations of each sector.
Validex Engineering is headquartered in Ireland, delivering on-site consultancy and engineering services to clients across the island — from Dublin to Galway, Cork to Limerick and beyond.
Whether you need a validation programme delivered on time, a QMS built from scratch, or precision CAD engineering for a new product — we would welcome the conversation.