Quality & Compliance | FDA & ISO 13485 Manufacturer | MeetingBoth
Global Regulatory Standards

Uncompromising Medical-Grade Quality

In the aesthetic device market, safety and efficacy are non-negotiable. Our Shenzhen facilities operate under strict ISO 13485 protocols, ensuring your OEM products effortlessly pass FDA, CE, and global customs clearances.

ISO 13485:2016
100% PASS RATE

Global Market Access

Certified for International Trade

We provide full documentation and compliance backing for your OEM devices, ensuring zero friction with customs or retail regulatory boards.

ISO

ISO 13485

MEDICAL QMS

Our facility strictly adheres to the internationally recognized Quality Management System standard for medical device manufacturing.

FDA

FDA Registered

US MARKET

Our manufacturing facility is FDA registered. We actively assist clients with 510(k) clearance documentation for Class II devices.

CE

CE Medical / EMC

EU MARKET

All devices pass stringent Electromagnetic Compatibility (EMC) and Low Voltage Directives (LVD) for safe European distribution.

RoHS

RoHS & REACH

MATERIAL SAFETY

We guarantee our PCB boards, silicones, and plastics are 100% free from hazardous heavy metals and toxic chemicals.

Inside Our In-House Testing Laboratory

  • Integrating Sphere Spectrometry

    We don’t guess the wavelength. Every LED batch is mapped in our integrating sphere to verify exact nanometer outputs (e.g., exactly 633nm) and irradiance (mW/cm²).

  • Thermal & Burn-In Testing

    Devices undergo grueling 48-72 hour continuous power-on cycles in high-heat incubators to ensure the battery and PCB will not fail or overheat during consumer use.

  • EMF Emission Verification

    For skin-contact devices like face masks and belts, our engineers test for Electromagnetic Fields to guarantee 0.0 µT emissions at the point of contact.

Scientific Rigor

Beyond Basic Assembly

A beauty device is only as good as the science validating it. Many cheap manufacturers assemble off-the-shelf parts with no verification of the actual optical output.

At MeetingBoth, our dedicated R&D engineers treat cosmetic devices with the same scrutiny as hospital-grade surgical tools. By testing every batch in our advanced optical and electrical labs, we protect your brand’s reputation and ensure your customers see genuine, clinical results.

0.1%
Defect Rate
100%
Battery Aging Tested

The Pipeline

Our 4-Stage Quality Control Protocol

We intercept and eliminate defects at every stage of the manufacturing journey, ensuring only flawless devices leave our Shenzhen facility.

IQC

Incoming Quality Control

We inspect 100% of raw materials before they enter the cleanroom. Medical silicones are checked for purity, LEDs for binning consistency, and batteries for voltage stability.

IPQC

In-Process QC

During assembly on our Class 100,000 cleanroom lines, inspectors constantly monitor soldering precision, wire routing, and initial power-on functions to catch assembly errors early.

FQC

Final Quality Control

Every single fully assembled device (not just a random sample) undergoes functional testing, LED intensity checks, and a mandatory battery burn-in stress test.

OQC

Outgoing QC

Prior to sealing the cartons, a final audit verifies that the packaging, custom manuals, accessories, and labeling perfectly match the client’s OEM specifications.

Partner With a Compliant Factory

Don’t risk your brand’s reputation with unverified suppliers. Trust MeetingBoth’s ISO 13485 certified infrastructure to deliver flawless, medical-grade beauty technology to your customers.

Request Compliance Documents