Orthodontics

Check whether the manufacturer holds CE MDR or ISO 13485 certification, and confirm the certificate scope covers the specific product line you are sourcing.

Bracket and appliance tolerances matter clinically. Ask for the slot dimension tolerance and the material specification for archwires.

For clear aligners, evaluate the thermoforming equipment type and the case designer team — the aligner is only as good as the software behind it.

Verify whether the supplier supports private-label manufacturing with your own packaging and labeling.

Ask for sterilization protocols on anything that contacts oral tissue — most single-use orthodontic items should arrive sterile.