A better science.
Leading Innovation in MedTech & Medical Device Clinical Research
As a European full-service CRO for medical devices and MedTech, Iberania delivers tailored clinical research and regulatory consulting services for startups and established manufacturers.
Our mission is to accelerate scientific and clinical development, enable safe and efficient market access, and build trusted long-term partnerships that bring meaningful health innovation to patients.
Your European Full-Service CRO for Medical Device & IVD
Our experience
With over 10 years of experience, our team has supported manufacturers across multiple regions in bringing medical devices and IVDs to the European market and maintaining compliance throughout their lifecycle. Our expertise also includes delivering training to sponsors, manufacturers, clinicians, researchers, and industry professionals on MDR/IVDR requirements and clinical investigation best practices.
Experience Across 250+ Clinical and Regulatory Projects in 25+ Countries
Per region
Per medical device phase
Over 60 training sessions delivered
Per topic
Our purpose
Iberania provides efficient clinical and regulatory solutions that support every stage of product research, development, clinical investigation, and commercialization.
Through our extensive experience, we identified a critical unmet need for specialized MDR & IVDR support and clinical strategy for pioneering MedTech and medical device companies. Iberania was founded to address these challenges and to act as an integrated partner throughout the entire innovation journey.
Our commitment extends beyond established manufacturers. We actively support public foundations, healthcare institutions, universities, and independent researchers, helping them navigate regulatory requirements and bring impactful technologies to market.
Our Services
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Includes the full design, set-up, conduct, monitoring, reporting, and oversight of clinical studies across Europe, the US, Canada, and APAC. At Iberania, we manage the complete end-to-end clinical investigation process, from study design and protocol development to site selection, regulatory submissions, monitoring, safety reporting, data management, and clinical study reporting. We adapt to each manufacturer’s needs, providing customized clinical research services for medical devices and IVDs under MDR/IVDR.
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Involves regulatory consulting and documentation development for your technical file and MDR/IVDR dossier. We support the preparation of the Clinical Evaluation Plan and Report (CEP, CER), Literature Review Protocol and Report (LRP, LRR), Post-Market Surveillance (PMS), Periodic Safety Update Report (PSUR), and the Summary of Safety and Clinical Performance (SSCP). Our goal is to ensure your clinical and regulatory documentation meets all EU requirements for conformity assessment and market access.
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Includes early-stage consulting and strategic guidance for MedTech and medical device companies. We help you understand the MDR/IVDR process, regulatory requirements, evidence expectations, and the steps required to bring your product successfully to the European market. Our strategic support ensures clear planning for clinical investigations, regulatory submissions, and market access.
