Hygiene & Safety
Our quality system meets GMP (Good Manufacturing Practice) requirements and for decades has ensured the conformity of our production, providing you with a guarantee of safety and hygiene.
Regulatory compliance
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
- US 510K files for our Vial Adapter
- MDSAP Certificate n°40112 rev0 for our Vial Adapter and Dosing Devices
- cDMF B20240000221 for our Dosing Devices
- MD15 ref IMP/MD/2024/000818 for our Vial Adapter
Quality and regulatory compliance are the backbones of our organisation.
Drug Master File (DMF) n°36044
Medical devices concerned:
- DOS'UP® measuring cups
- DOS'UP® dosing syringes
- DOS'UP® Spoons
- DOS'UP® Plus pipettes
- APPLISIL® applicators
Control
- 3 metrology laboratories
- 300 managed control appliances
Regulatory expertise
- Management of medical device registration, CE marking, and UDI traceability (MDR compliance)
- Delegation of controls
Uncompromising quality
Certified NF EN ISO 13485 and NF EN ISO 15378, Union Plastic manufactures and packages under controlled environments and has clean room production lines classified ISO 7 and ISO 8, a guarantee of the quality of our products.
