Compliance

Certifications for OEM buyers

ISO · FDA · CE / EU MDR · SGS testing — one hub for vendor due diligence

Vendor gates

What B2B buyers should request

Retail, pharmacy, and marketplace onboarding need layered evidence — not a single PDF. Use this page for ISO, FDA, CE, and SGS scope; deep regulatory reading lives in our EU vs FDA pathway guide and vendor compliance guide.

A practical pack includes: QMS certificate with scope, establishment registration proof where relevant, technical-file table of contents for CE paths, third-party test indexes, and lot COA samples. Certificates expire and scopes change — verify dates and product coverage before PO.

Framework

ISO quality system

ISO is the backbone buyers check first: design controls, supplier management, production validation, batch traceability, and CAPA. Source Cup maintains medical-device-oriented QMS discipline for cup and disc OEM — not ISO 9001-only claims. Request scope lines and surveillance status during due diligence. Lot travelers link material COAs to finished goods for pharmacy and marketplace vendor packs.

Framework

FDA establishment registration

US-bound brands need manufacturer establishment context, production records, and labeling that match general controls for menstrual cups/discs. We support documentation packages used in importer and marketplace onboarding. Share your listing pathway early so we align device description language, UDI/label needs, and lot release evidence with your regulatory consultant.

Framework

CE marking & EU MDR support

European retail and pharmacy channels expect technical-file structure: device description, risk management, verification/validation, clinical evaluation summary inputs, and PMS planning — coordinated with multilingual IFU. Source Cup supplies manufacturer evidence layers; brand owners remain responsible for Declaration of Conformity and market authorization roles. Pair with packaging/IFU work on the OEM hub.

Framework

SGS & third-party testing

Independent lab reports (SGS or equivalent) cover material and product performance panels buyers put in risk files: biocompatibility-related summaries, chemical restrictions, and lot-linked indexes. We provide report number indexes under NDA when required and re-test on material or pigment changes under change control.

Certifications FAQ

Which certifications does Source Cup provide for OEM brands?

ISO quality system evidence, FDA establishment registration support, CE / EU MDR technical-file inputs, and SGS (or equivalent) third-party test reports — summarized in the sections below.

Can I request a compliance pack for vendor onboarding?

Yes — certificate indexes, COA templates, and report samples via our inquiry form. Note destination markets and channel (pharmacy, Amazon, DTC).

How do certifications connect to packaging and private label?

CE/FDA pathways require IFU and labeling coordination — see private label and OEM hub packaging notes.

Where is manufacturing evidence behind these certificates?

Process, QC, and material controls are documented on the manufacturing hub.

Need a market-specific compliance pack?

Tell us destination countries and channel — we map ISO / FDA / CE / test evidence to your vendor checklist.

Request pack

OEM services