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, documentation pack, and SGS scope; deep regulatory reading lives in our EU vs FDA pathway guide and supplier scorecard.

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

Quality records

Ask for the documentation pack that matches the SKUs on your PO. We send film grade, lot notes, and any third-party reports we hold for that grade. We do not publish ISO, FDA, or CE badges unless the paper exists for this converting line.

Framework

FDA establishment registration

US-bound brands need manufacturer establishment context, production records, and labeling that match general controls for packing tape/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. AeroTape 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 tape documentation pack can AeroTape send?

A documentation pack on request for the SKUs on the PO: film grade, lot notes, and any third-party reports we hold for that grade. We do not publish cert numbers we cannot show.

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 / documentation pack / test evidence to your vendor checklist.

Request pack

OEM services