Pelican Tech provides comprehensive regulatory services, from strategy development to market approval. Our experts act as an extension of your regulatory team.
From submissions to post-market surveillance, we ensure your innovations reach patients safely.
Support for CE Marking (EU MDR/IVDR), FDA 510(k), PMA, De Novo, and international dossiers.
Development of comprehensive regulatory strategies for successful market entry worldwide.
Precise review and creation of labeling and Instructions for Use to meet strict compliance standards.
Ongoing PMS and incident reporting to ensure continued safety and compliance.
Assistance with selecting and managing Notified Bodies and European Representatives.
Rigorous internal audits to identify gaps and prepare for external inspections.