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Quality & Compliance

Quality You Can Verify

Anyone can list logos. We give you certificates you can verify — the same quality system behind FDA-cleared home-use devices.

Certifications

Certifications & Compliance

Every certificate is verifiable — scans available under NDA.

ISO 13485
:2016

Medical Devices QMS. Governs design, development, production, and servicing of medical-grade products with enhanced regulatory requirements.

ISO 9001
:2015

Quality Management System. Ensures consistent product quality, process efficiency, and continuous improvement across all manufacturing operations.

CE

European conformity declaration. Ensures health, safety, and environmental protection standards for products sold throughout the EU and EEA.

FDA

Food and Drug Administration. Essential for medical devices, ensuring safety, efficacy, and quality for US healthcare-market access.

FCC

Federal Communications Commission compliance. Required for electronics using radio frequencies sold in the United States market.

RoHS

RoHS compliance, product-specific test reports, and market-specific certifications available on request per your regulatory requirements.

History

Certification Timeline

2005

FCC & CE certifications achieved

2015

ISO 9001 & ISO 13485 dual certification

Ongoing

Product-level certifications per market

Today

Global compliance for 50+ countries

Come See the Factory Yourself

The fastest way to evaluate a manufacturing partner is to walk the floor. We host brand teams from the US, Europe, and Japan — book a tour, or start with a quote.

Book a Factory Tour