IFU printing and folding for regulated products
IFU Printing & Folding

IFU Printing & Folding

Instructions for Use printed and folded to your exact specifications — multi-panel, fan-fold, booklet, and accordion formats for regulated medical and pharmaceutical products.

Overview

Precision IFU Production for Regulated Products

Instructions for Use documents are a regulatory requirement, not an afterthought. We print and fold IFUs to tight dimensional tolerances, manage artwork revisions with full version control, and ship with the same compliance documentation package as every other order — Certificate of Conformance, batch record, and inspection report included.

Minimum Order1,000 units
Standard Turnaround10 business days
Print MethodDigital, high-resolution
LanguagesMulti-language layouts supported
SubstratesUncoated, coated, and specialty papers
Fold Tolerance±0.0625" dimensional tolerance
Available Formats

IFU Folding Formats

Multi-Panel Leaflet

Single-sheet, multi-fold formats for compact packaging inserts. Common for unit-dose pharmaceuticals and small device kits.

Fan-Fold / Z-Fold

Accordion-style folding for longer documents that must fit inside a carton. Ideal for combination products and multi-language IFUs.

Booklet Insert

Saddle-stitched or glued booklets for complex instructions requiring multiple pages. Supports multi-language requirements in a single document.

Roll-Fed Continuous

High-volume roll-fed IFU production for automated insertion into packaging lines. Available for larger production runs.

Compliance Documentation on Every IFU Order

Certificate of Conformance

Signed CoC confirming the IFU meets all specified dimensional and print requirements.

Artwork Revision Log

Version-controlled record of all artwork approvals — critical for 510(k) submissions and technical files.

Batch Record with Lot Traceability

Full production record with lot number and materials traceability for every IFU run.

Inspection Report

Dimensional and print quality inspection results against approved specifications.

Applications

Who Uses Our IFU Services

Pharmaceutical

Package inserts and patient information leaflets for Rx and OTC drug products under 21 CFR Part 211.

Medical Device

Instructions for Use for Class I, II, and III devices — formatted to meet IEC 82079-1 and ISO 15223 symbol requirements.

Diagnostics

Multi-language IFU inserts for in vitro diagnostic kits, including rapid test and point-of-care formats.

Combination Products

IFUs for drug-device combination products requiring coordinated labeling across both regulatory pathways.

Ready to spec your IFU run?

Submit your format, dimensions, and quantity. We'll turn around a quote within one business day.

MBM Packaging 30th Anniversary

Operated by MBM Packaging
Rogersville, Tennessee

FDA-Registered Facility
Established 1997

Compliance

  • FDA-Registered Facility
  • cGMP-Compliant Production
  • Certificate of Conformance
  • Batch Records — Every Order
  • 21 CFR Part 211 Packaging

Contact

MBM Packaging

Rogersville, Tennessee

FDA REGISTERED · EST. 1997

FDA Establishment Registration No. 3014553709. Registration of an establishment does not denote FDA approval, certification, or endorsement.

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Short-run folding cartons & IFUs for regulated industries.