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.
Most B2B menstrual cup programs need a layered pack: ISO 13485 for manufacturing quality system credibility, FDA establishment support for US import and listing alignment, CE / EU MDR technical-file inputs for European retail, and SGS or equivalent material and biocompatibility reports for brand and marketplace risk review. Certificates alone are not enough — buyers should request scope statements, surveillance dates, and lot-linked COAs when products ship.
Furuize prepares OEM document bundles for private label and wholesale partners: quality agreements, test report indexes, labeling and IFU coordination notes, and batch release samples. Use the pages below for each framework, then open a compliance pack request with your destination markets and channel (DTC, Amazon, pharmacy, distributor). Pair certifications with factory evidence on the manufacturing hub before first PO.
We do not treat certificates as marketing wallpaper. Evidence is maintained under change control so material or process updates trigger appropriate re-testing and customer notification pathways agreed in writing.
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