---
id: silicraft/okf/compliance
title: Factory and material documentation
last_updated: 2026-09-29
canonical: https://silicraft.lumorb.com/okf/compliance.md
---

# Factory and material documentation

A standard named on a product page is not proof that a component, material or factory meets it. Check the exact entity, site, certificate scope, validity and tested formulation. Material evidence does not replace finished-device evaluation.

- [Food-contact documentation](https://silicraft.lumorb.com/guide/fda-21-cfr-177-2600)
- [Medical silicone evaluation](https://silicraft.lumorb.com/guide/medical-grade-silicone)
- [ISO 13485 and FDA QMSR](https://silicraft.lumorb.com/insights/iso-13485-vs-fda-21-cfr-820)

These guides link primary sources. The required documentation depends on intended use and destination market.