COMPLIANCE & QUALITY
Quality and Documentation for Your Brand
Rebeatec supplies red light and LED care products for brands, distributors, and wholesale partners. We support OEM/ODM projects with product
specifications and available testing and compliance documentation to help your team evaluate products for its target markets.
Documentation availability varies by model and configuration. Contact us to confirm the certificates, test reports, and customization options available for your selected products.
ISO 13485:2016
Quality Management System for Medical Devices
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MDSAP
Medical Device Single Audit Program
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IEC 60601-1
Medical Electrical Equipment — Basic Safety and Essential Performance
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CE
European Conformity
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FDA 510(k)
US FDA Premarket Notification
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ISO 14001
Environmental Management
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ISO 45001
Occupational Health & Safety
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ISO 9001
Quality Management System
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EMC
Electromagnetic Compatibility
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RoHS
Restriction of Hazardous Substances
View certificate →Building a Regulated Beauty or Wellness Brand?
Talk to our regulatory and OEM team about certification-ready product development for your target markets 鈥?FDA, CE, TGA and beyond.
Request Compliance Documents