Baby and infant brands sold in the United States have to meet a stack of regulations that overseas factories often work around rather than to. We operate to them by default:
- USP Class VI - biocompatibility standard for materials with external body contact.
- ISO 13485:2016 - medical device quality management, with the traceability and process validation that come with it.
- Permanent CPSIA tracking labels - manufacturer name, production location, date, and batch on every part and every package.
- 100% US-Based Manufacturing – Protect your intellectual property, simplify audits, and reduce supply chain risk
- Full Traceability & Lot Documentation
