Quality & Compliance
Compliance cleared before production. Certificates on request.
Certifications are held across our partner network and verified for every order before production — the documents your tender or audit team asks for.
Across our network
FDA Registration · FY 2026
U.S. facility registration
Across our network
CE Marking
European conformity marking
Across our network
ISO Certification · ICAS
Management systems certified through ICAS
Across our network
ISO Certification · NOA
Management systems certified through NOA
Across our network
SMETA · Powered by Sedex
Ethical trade audit
Across our network
ISO 13485 · 9001 · 14001
Quality, medical device & environmental systems
Certified across our partner network — verified per order. Copies on request.
Market Coverage
Which certification unlocks which market
| Certification | Applicable Markets | Applicable Products |
|---|---|---|
| CE | EU | Applicable hygiene & medical product lines |
| FDA | United States | Regulated hygiene & incontinence products |
| ISO 13485 | Global — medical | Medical-tier incontinence & care products |
| ISO 9001 | Global — quality | All manufactured categories |
| ISO 14001 | Global — environment | All partner facilities and processes |
| SMETA | Europe — retail buyers | Social compliance for retailer audits |
Product Grades
Medical-grade vs civil-grade lines
Not every product needs the same compliance level — we build the right grade for your channel.
Medical Grade
For institutional & regulated channels
- ISO 13485-aligned quality management
- CE / FDA applicable product compliance
- High-SAP cores, wetness indicators
- Documentation support for tenders
Civil Grade
For retail & e-commerce channels
- ISO 9001-aligned quality management
- Economic to premium tiers
- Consumer-focused packaging & print
- Flexible mixed-SKU containers
Certifications are verified for every order before production. Certificate copies available on request.
For Your Tender or Audit
Need certificate copies for your tender or audit?
Request the current certificate set — we'll share valid copies and answer scope questions for your specific product and market.