manufacturing of medical devices
Fluisense designs, develops and manufactures our own wearable devices for serial blood sampling.
Fluisense also offers Contract Manufacturing in compliance with EN ISO 13485.
Class 8 clean-room for:
- Manufacturing of small batches of sterile medical devices
- Silicone molding
- Prototype products for clinical investigations
- Assembly and primary packaging for sterilization
- To get up and running fast
ESD Assembly area
- ESD protected assembly of electronic medical devices
Fluisense currently has manufacturing capability to spare.
We currently manufacture in accordance with theSE standards:
EN ISO 13485:2016
EN ISO 14971:2019 Risk Management for Medical Devices
EN ISO 10555-1:2013/A1 2017 Sterile, single-use intravascular catheters
EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices
EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices
EN ISO 14644-1:2015 Cleanrooms and associated controlled environments
EN ISO 14698-1 and -2 - Cleanrooms and associated controlled environments - Biocontamination Control.
Contact us to learn how we might help you.