Uncompromising Quality &
グローバル・コンプライアンス
For B2B medical and beauty brands, compliance is non-negotiable. COLORDIAMONDS operates under a strict Total Quality Management (TQM) framework, ensuring every phototherapy device meets the rigorous legal and safety standards of North America, Europe, and global markets.
Internationally Recognized Standards
We eliminate customs friction and legal risks for our wholesale partners. Our manufacturing facility and product lines are audited and certified by leading global regulatory authorities.
ISO 13485:2016
The ultimate standard for medical device manufacturing. Our entire quality management system—from R&D and component sourcing to final assembly—is audited to ensure consistent clinical-grade output.
FDA Registration
COLORDIAMONDS is an FDA-registered facility. We strictly adhere to 21 CFR Part 820 (Quality System Regulation). We routinely assist clients in obtaining FDA 510(k) clearances for Class II phototherapy devices.
CE (MDR & EMC)
All our LED therapy panels and handheld devices carry genuine CE marks. We provide complete Technical Files, Declarations of Conformity, and pass rigorous Electromagnetic Compatibility (EMC) and safety directives for the EU.
RoHS & REACH
We guarantee toxic-free supply chains. Our liquid silicones, ABS plastics, and internal PCBs are 100% compliant with RoHS and REACH regulations, ensuring environmental safety and preventing hazardous substance disputes at customs.
The 4-Stage QC Loop
A defect found by a consumer damages your brand; a defect caught by our factory protects it. We deploy a multi-layered inspection protocol for every B2B order.
Incoming Quality Control
Before assembly begins, all raw materials are quarantined. We sample-test incoming LED chips for wavelength accuracy using spectrometers, verify battery capacities, and inspect raw silicone for medical-grade purity. Any batch failing AQL (Acceptable Quality Limit) standards is immediately returned to suppliers.
In-Process Quality Control
During SMT processing and manual assembly inside our Class 100,000 cleanrooms, line inspectors continuously monitor production. We conduct first-article inspections and hourly spot-checks. This includes automated optical inspection (AOI) of PCBs to detect soldering defects before they are encased in the device housing.
Final Quality Control & Aging
Every completed device—whether it's an LED Face Mask or a PDT System—undergoes 100% functional testing. This is followed by our mandatory 48-hour continuous aging process in temperature-controlled chambers to expose any latent electronic failures or battery degradation prior to packaging.
Outgoing Quality Control
The final gatekeeper. Before pallets are loaded for export, QA managers conduct a randomized inspection of the packaged goods according to MIL-STD-105E standards. We verify packaging integrity, shipping marks, barcode readability, and user manual inclusion to ensure a flawless unboxing experience for your retail customers.
Regulatory Affairs Support
Navigating global medical device regulations can delay product launches by months. As an experienced B2B manufacturer, COLORDIAMONDS provides comprehensive Regulatory Affairs (RA) support to fast-track your market entry.
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Technical Dossier Compilation
We supply you with complete bill of materials (BOM), clinical trial data (where applicable), risk management files, and biocompatibility test reports required for your local health ministry submissions.
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Customs Clearance Assistance
We pre-emptively resolve import issues by providing precise HS Codes, commercial invoices, packing lists, and Certificates of Origin (CO) tailored to your destination country's requirements.
Request Our Quality Manual & Certificates
Evaluating a new manufacturing partner? Contact our compliance team to request high-resolution copies of our ISO 13485 certificates, FDA registration numbers, and a blank Certificate of Analysis (COA) sample.
For video audits or to arrange an on-site facility inspection, please email us directly.
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