Safety and compliance are built into the process.
Our quality management system covers every stage of the product's life, from design to manufacturing to post-market follow-up.
What our quality system covers
Design controls
Documented requirements, verification and change control.
Risk management
Hazards identified, controlled and reflected in labeling.
Production controls
Supplier control, inspection and release testing.
Post-market
Complaint handling and adverse event reporting.
Every unit, traceable.
Each Modus-F carries a unique device identifier. Its serial number links to a device history record covering components, assembly, test results and shipment.
- Unique device identifier (UDI) on every unit
- Device history record per serial number
- Shipment records through to the US distributor
- Complaint and service history linked to the unit
How we keep our US presence compliant
One product
Only Modus-F is offered in the US, for its stated intended use.
Separate sites
US visitors see this site only; international products stay on incelermedikal.com.
Defined intended use
Modus-F is presented only for its intended use, in the exact US wording.
One support path
Sales, service and problem reports routed through one authorized US distributor.