OUR DEDICATED MEDICAL ORGANISATION
A proven organisation
- Dedicated test & follow-up service
- Mastered qualification process according to customer standards
- Production in 3 shifts + WEEK-END
- R&D team. Support for customers in the implementation of their needs
THERMI-PLATin medical
OUR EQUIPMENTS
9 COATING MACHINES
4 PVD and 4 DLC machines
1 R&D and DLC machine
Inter-site security
4 CLEANING MACHINES
Detergent
Modified alcohol
2 CONTROL MACHINES
2 Non-destructive thickness testing machines
THICKNESS MEASUREMENTS ON PARTS
PVD COATING
Use of X-ray fluorescence technology
Allows thickness measurements directly on the part without destroying it.
DLC DEPOSITS
Use of infrared technology
Allows thickness measurements directly on the part without destroying it.
CERTIFICATION PROCESS
Creation of an IT portal
Qi (IQ – Installation Qualification) Qo (OQ – Operational Qualification)
Qp (PQ – Performance Qualification)
Management of qualification files (testing, validation, traceability and data archiving)
Creation of a medical file for each device
Risk approach
Risk analysis in partnership with the customer
Carrying out tests and tooling via a specific cell
Validation of serial conditions
ISO 13485 certified organisation
