Quality & Regulatory
Quality you can document.
[Describe your quality management system and regulatory approach.] Certification details on this page are updated only with verified information.
Quality management
Quality in every step, from design to delivery.
[Describe how quality is managed: QMS scope, standards followed, inspection and release.]
Standard sizes and custom sizes go through quality control before delivery.
[Quality management system]
[Short description — replace with your actual process.]
[Document control & traceability]
[Short description — replace with your actual process.]
[Production & inspection]
[Short description — replace with your actual process.]
[Post-market surveillance]
[Short description — replace with your actual process.]
Regulatory status
Where we stand, market by market.
Only Taiwan TFDA is confirmed as in progress. All other rows are placeholders until verified.
| Region | Authority / standard | Status | License / certificate no. | Scope |
|---|---|---|---|---|
| Korea | MFDS (Ministry of Food and Drug Safety) | [Status] | [No.] | [Scope] |
| European Union | CE marking (EU MDR) | [Status] | [No.] | [Scope] |
| United States | FDA | [Status] | [No.] | [Scope] |
| International | ISO 13485 (quality management system) | [Status] | [No.] | [Scope] |
| Taiwan | TFDA (Taiwan Food and Drug Administration) | In progress | — (application in progress) | Size range, including custom sizes · with Taiwan partner [Partner name] |
Documentation
Regulatory documents for partners.
Distributors and regulatory partners can request documentation through the contact form. A Free Sale Certificate is often needed for registration in markets such as Taiwan.
- Free Sale Certificate (FSC) [confirm availability and issuing authority]
- [Declaration of conformity]
- [Instructions for use (IFU)]
- [Certificates — ISO 13485 / others]