Compliance Hub
Menstrual Cup Certifications
Compliance Evidence Hub
ISO 13485 • FDA Registration • CE Marking • SGS Testing
Documentation for Retail, Pharmacy & Marketplace OEM Brands
Vendor Gates
Certification Portfolio for B2B Buyers
Retail, pharmacy, and marketplace onboarding each require different compliance evidence — this hub maps Furuize QMS, regulatory, and third-party test documentation for vendor due diligence. See EU MDR vs FDA OEM pathway and our marketplace vendor compliance guide for regulatory context.
Certification & Testing Pages
Click through for scope detail, documentation lists, and OEM implications
ISO 13485 Quality System
Medical device QMS scope for cup & disc OEM, batch traceability, and surveillance audits.
FDA Establishment Registration
US registration pathway, production records, and labeling support for American brands.
CE Marking & EU MDR
Technical file components, risk management, and IFU coordination for European markets.
SGS Third-Party Testing
Independent silicone safety, mechanical, and migration reports for global buyers.
Certifications Hub FAQ
Which certifications does Furuize provide for OEM brands?
ISO 13485 QMS, FDA establishment registration, CE MDR technical file support, and SGS third-party test reports — each detailed on dedicated pages below.
Can I request a compliance pack for vendor onboarding?
Yes — certificate indexes, COA templates, and report samples via compliance inquiry or resources center.
How do certifications connect to packaging and private label?
CE/FDA pathways require IFU and labeling — pair with packaging OEM and private label launch programs.
Where is manufacturing evidence behind these certificates?
Factory QC and lab data on quality control and testing lab pages.
Related Compliance & OEM Resources
Need a Compliance Pack for Your SKU Line?
Request ISO, FDA, CE, and SGS documentation samples with your OEM inquiry