As a global expert in drug delivery devices production, we provide to our customers a regulatory compliance in the major global areas :
- EU MDR/2017/745 EC certification for our class 1m and 1s medical devices.
- ISO13485 & ISO15378 compliance
- US DMF n°36044 for our dosing devices
- MDSAP Registration
- cDMF B20240000221 for our Dosing Devices
- MD15 ref IMP/MD/2024/000818
Quality and regulatory compliance are the backbones of our organisation.
Do not hesitate to ask for more information and the support of our regulatory departement for specific registration.
