02
Services / Products
Medical Devices
We have been accompanying
medical device manufacturers
for over 10 years
-
regulatory strategy and marketing
-
Initiation and quality system management
-
Compliance
with the new
European
regulationEuropean regulation 2017/745
notified bodies, ce marking -
Clinical evaluations
-
Clinical
investigationsSecurity and performance
-
Medical & economic evaluation
Post-marketing surveillance plan
Real-world study (usage conditions, benefit and risk assessment, etc.)