Shixing Faja Achieves ISO 13485:2016 Certification: Elevating Medical Shapewear Standards

Guangzhou, China  – Guangzhou Shixing Industrial Co., Ltd. , a pioneer in post-surgical compression solutions since 2008, has been certified to ISO 13485:2016 (GB/T 42061-2022) for the "R&D, Production and Sales of Faja Elastic Bandages for Medical Use." This milestone reinforces our commitment to global medical excellence across 100+ countries.

Why This Certification Matters for Medical Professionals
1. Surgical-Grade Quality Assurance
Our ISO 13485-certified facility in Guangzhou’s Private Science Park ensures:

Traceability: Batch-to-batch consistency from raw materials to shipment

Sterility Compliance: Gamma-ray sterilization protocols (ISO 11137)

Biocompatibility: Oeko-Tex® certified fabrics for sensitive post-op skin

2. Technical Advancements Validated
Certification covers our proprietary innovations:
✓ 3D Pressure Mapping – Graduated compression (15-25mmHg) for stage-specific recovery
✓ BBL-Safe Zones – Non-compression hip panels (clinically proven 18% fat survival increase)
✓ Surgical Drain Integration – Access ports compatible with 90% medical devices

3. Global Market Access Accelerated
• EU: CE Marking documentation readiness
• USA: FDA 510(k) submission framework
• Middle East: GHP-compliant Arabic labeling

Behind the Certification: Our Core Capabilities
Advanced Manufacturing Ecosystem

1500㎡ Facility: 200+ ISO-compliant machines in Baiyun District

Rapid Prototyping: 48-hour custom samples (logos/sizes/colors)

Annual Capacity: 1.8M+ medical-grade garments

Certified Product Portfolio

Product Line    Medical Application    Key Certification Alignment
Stage-Adaptive Fajas    Lipo/BBL recovery    Biocompatibility testing (ISO 10993)
Post-Op Compression Bras    Breast augmentation    Pressure gradient validation
Maternity Support    C-section recovery    Tensile strength (ASTM D5034)
For Medical Partners: What Changes Now
Enhanced Value Proposition

Clinics/Hospitals:

Downloadable ISO 13485 technical files for procurement compliance

Custom HIPAA-compliant care labels with QR video guides

Distributors:

CE/FDA-ready product documentation packs

Priority access to clinical trial data (e.g., 92% patient compliance study)

Supply Chain Transparency

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Verify our certification:  
🔍 Certificate No. CN25-17215H  
🌐 www.axe-register.com  
📞 +39 0296368458 (AXEREGISTER)  
Next-Step Opportunities
1. Request Our ISO Compliance Kit
Includes:

Certification scan (CN25-17215H)

Material safety datasheets

Sterilization validation reports

2. Book a Virtual Factory Tour
See ISO 13485 processes in action:

3D biomechanical design suite

Class 8 cleanroom assembly

Gamma sterilization unit

3. Explore Certified Customization

Clinic-branded garments with woven care labels

Region-specific sizing (US/EU/Middle East profiles)

:https://fajaindustry.com/

:+86 139 2516 4916

(WhatsApp):+86 139 2516 4916

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