Service
EU Authorised Representative (EUAR) Service
We act as your EUAR, ensuring non-EU companies seamless EU market entry—from EUDAMED registration to post-market vigilance.
- Consulting
Author
Director at Med-Di-Dia Limited
Galway, Galway, Ireland
Med-Di-Dia Limited
About
At Med-Di-Dia, we believe that successful healthcare innovation depends on strong, reliable partnerships. We work closely with companies of all sizes to navigate the regulatory and quality challenges that shape today’s global medical markets. With deep expertise across medical device, diagnostics, and digital health pathways, we translate complex requirements into clear, practical steps that support confident decision-making and timely market access.
Our team provides tailored regulatory strategies, robust quality management solutions, and hands-on support throughout the entire product lifecycle. Whether you are preparing for certification, scaling internationally, or strengthening your compliance framework, we help you move forward with clarity, efficiency, and peace of mind.
By combining technical insight with a collaborative, solution-driven approach, we ensure that you always have a trusted partner at your side—one who is committed to delivering compliance excellence and enabling your innovation to reach the patients and markets that need it most.
E-HEALTH
Safety & systemsSensors & Wireless productsRemote diagnostics
LIFE SCIENCE
Diagnosticse-Health and ICT solutionsEmergency Medicine, Rescue EquipmentHospital and Care equipmentImaging processingLaboratory EquipmentOperating technology and equipmentPhysiotherapy, Orthopaedic TechnologySterilisationSurgery and Endoscopy
VALUE CHAIN
Auditing & AnalyzingComponents / MaterialsDesign / R&D / EngineeringOEM (Original Equipment Manufacturer)ProductionSales & DistributionSoftware & App Development
ROBOTICS AND AUTOMATION
AI guided robotics and automationSensor networks
THERAPEUTIC AREA
Cardiology/Vascular DiseasesDental & Oral HealthDermatologyDiagnosticsEndocrinologyGastroenterologyGenetic DiseaseHematologyHepatologyImmunologyInfections and Infectious DiseasesInternal MedicineMusculoskeletalNephrologyNeurologyNutrition and Weight LossObstetrics/GynecologyOncologyOphthalmologyOrthopedics/Orthopedic SurgeryOtolaryngologyPediatrics/NeonatologyPharmacology/ToxicologyPodiatryPsychiatry/PsychologyPulmonary/Respiratory DiseasesRare DiseaseRheumatologyTraumaUrologyVaccines
INTELLECTUAL PROPERTY, LEGAL AND FINANCIAL SERVICES
Regulatory affairs
MEDICINE
Diagnostics, DiagnosisMedical FurnitureMedical Technology / Biomedical EngineeringMedical TextilesPhysiotherapy, Orthopaedic TechnologySingle Use Products and Consumer GoodsStem cell Technologies
Representatives
Director
Med-Di-Dia Limited
Marketplace (5)
Service
ISO 13485 Excellence: Med-Di-Dia’s Proven Quality Management Expertise
Med-Di-Dia delivers expert ISO 13485 QMS development, implementation & compliance support for innovative medical device and IVD companies.
- Consulting
AuthorDirector at Med-Di-Dia Limited
Galway, Galway, Ireland
Service
Smart Risk Classification Support for Medical Device Developers
Smart, guided risk classification support to help medical device developers navigate MDR/IVDR/USFDA requirements and accelerate compliance
- Consulting
AuthorDirector at Med-Di-Dia Limited
Galway, Galway, Ireland
Service
Data-Driven Roadmaps for Regulatory Navigation when entering new markets
Clear, step-by-step regulatory roadmaps to help MedTech companies enter new markets with confidence and faster compliance.
AuthorDirector at Med-Di-Dia Limited
Galway, Galway, Ireland
Service
UK Responsible Person (UKRP) Service to provide seamless entry into the UK
UKRP service ensuring full compliance with British regulations, seamless oversight, and secure market access for your medical devices.
AuthorDirector at Med-Di-Dia Limited
Galway, Galway, Ireland