Outsourced steps mean lost control
Every handoff to a subcontractor adds variability and a schedule you don't own. If saturation, cutting or sealing is done elsewhere, a quality issue or a delay there becomes your problem — discovered late.
One roof, one quality system
We keep the whole line in-house, so every batch runs under one ISO 13485:2016 quality system: batch records and traceability, COA per lot, and release testing before shipment. Consistent inputs and process control mean consistent specs, lot after lot.
On-time by design
Owning the line means owning the schedule. Standard orders ship in 15–25 working days after PO and deposit; urgent orders can move by air freight; OEM with new printed packaging adds only the print-approval window. No queue behind another factory's jobs.
What you get with every order
- ISO 13485:2016 batch control and traceability
- COA per lot
- EU Declaration of Conformity available
- Reliable 15–25 day lead times
Frequently asked questions
Do you outsource production?
No. Our production lines are self-designed and run in-house, so the whole process stays under our ISO 13485:2016 system.
What quality documentation do you provide?
ISO 13485:2016 batch control with traceability, a COA per lot, and an EU Declaration of Conformity on request.
What is your standard lead time?
15–25 working days after PO and deposit, with air freight available for urgent orders.
