1. (System & Factory Certifications)

Q1: What Quality Management Systems (QMS) does your factory hold?
A1: We are fully certified with ISO 13485 (Medical Devices QMS), ISO 9001 (Quality Management), ISO 14001 (Environmental Management), and ISO 45001 (Occupational Health and Safety). Our production processes strictly adhere to global medical and textile manufacturing standards.

2.  (CE / FDA Compliance Support)

Q2: We need CE and FDA registration for our local market. Can you assist with compliance?

A2:

Absolutely. As a customer-oriented OEM/ODM manufacturer, we actively collaborate with global importers for market-specific compliance. Based on actual circumstances, we can provide the required technical documentation, product test reports, and factory inspection support to help you smoothly obtain CE, FDA, or other local import registrations.

3.  (BSCI / SMETA / OEKO-TEX)

Q3: Can your factory meet social compliance and fabric safety standards like BSCI, SMETA, or OEKO-TEX? 

A3: Yes! While maintaining strict ISO management standards, we are ready to cooperate with third-party audits for BSCI and SMETA. For our functional and adaptive apparel lines, we source materials that meet OEKO-TEX Standard 100 requirements to ensure safety, skin-friendliness, and eco-friendly standards.

4.  (Quality Control & Testing)

Q4: How do you ensure product quality before shipping?

A4:

We implement a 4-step Quality Control system under ISO 13485 standards: IQC (Incoming Material Quality Control), IPQC (In-Process Quality Control), FQC (Final Quality Control), and OQC (Out-going Quality Control). Key protective products undergo physical testing, including hydrostatic pressure, tear resistance, and closure durability tests.

5.  (Adaptive Apparel Standards)

Q5: What safety and comfort standards do your Adaptive Apparel and Medical Textiles follow?

A5:Our adaptive apparel is specifically designed for seniors, bedridden patients, and individuals with limited mobility. We strictly adhere to key industry standards for safety, comfort, and durability:

Skin Safety & Environmental Standards: Materials are OEKO-TEX® Standard 100 certified (or tested to equivalent GB 18401 Class A/B standards), ensuring fabrics are free from harmful chemicals, non-irritating, highly breathable, and gentle on sensitive skin.

Industrial Washability & Durability: Fabrics and trims (such as Velcro, smooth side zippers, and magnetic closures) undergo colorfastness, anti-pilling, and tensile strength testing under ISO/AATCC standards to withstand frequent high-temperature washing and caregiver pull forces.

Functional Options: Antimicrobial and stain-resistant finishes can be integrated upon request to meet specialized healthcare environments.

6. OEM / ODM  (Customization & Private Label)

Q6: Do you offer full OEM/ODM services, including custom branding and packaging?
A6: Yes. We offer one-stop OEM/ODM solutions, including custom garment designs, material selection, private labeling, barcode printing, and retail-ready packaging that complies with target market labeling regulations.

7.  (Sample & Audit Support)

Q7: Can we request pre-production samples and conduct a factory audit before placing a bulk order? 
A7: Yes, we strongly encourage it. We can provide pre-production samples with test reports for your verification. We also welcome on-site factory visits or remote virtual audits (via video call) to show our production lines and cleanrooms.

8.  (MOQ & Lead Time)

Q8: What is your typical Minimum Order Quantity (MOQ) and production lead time? 

A8: MOQ depends on product specs and customization requirements (e.g., standard disposables vs. custom adaptive garments). Generally, our production lead time is 15-30 days after sample approval and deposit confirmation. We also support trial orders for long-term partners.