Our proactive expert team provides end-to-end solutions for medical devices and diagnostics, ensuring your data meets the highest standards while accelerating product development from concept to patient.
Medical Devices and IVD
A fully integrated service offering supporting medical device, IVD, and AI-based technologies across clinical validation, regulatory approval, and quality systems – aligned with EU MDR, FDA, and global standards across three pillars.
Services Across Lifecycle
Clinical Evidence & Trial Execution
We generate the clinical data required for CE marking, PMCF, and market access.
Core services:
Regulatory Strategy, CE Marking & AI Compliance
We ensure your device, software or AI System meets EU MDR and future-proof regulations.
Core services
Quality Systems That Pass Audits and Scale with Growth
We build and maintain audit-ready quality systems aligned with MDR, ISO and MDSAP.
Core Services:
CE MARKING OR REGULATORY APPROVAL
Total time to EU Market Access:
8-5 months
4-5 months
Process for QMS for ISO 13485
15 months
Process getting CE mark & months
“Biostatistics is the core of clinical trial management, driving precision and reliability throughout the process. It involves developing the study design, defining outcome measures and endpoints, conducting statistical analyses, evaluating risk-benefit assessments, and providing clinical interpretation of study results.”
Dr. med. Gheorghe Nicusor Pop
Clinical Operations
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