- Creation of US Pre-Market Notification (510k)
- Creation of Technical Documentation according to New EU Medical Device Regulation
- Consolidation and/or interpretation/translation of Common Submission Dossier Template (CSDT) according to ASEAN MDD (AMDD) for Importer
- Creation of Common Submission Dossier Template (CSDT) for manufacturer according to ASEAN MDD (AMDD)
- Creation of Technical Documentation according to European Medical Device Directive (93/42/EEC)
SIC - SMART INSIGHT CREATION
SMART INSIGHT CREATION
START YOUR REGULATORY JOURNEY ON THE RIGHT WAY.