Instructions for Use printed and folded to your exact specifications — multi-panel, fan-fold, booklet, and accordion formats for regulated medical and pharmaceutical 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.
Single-sheet, multi-fold formats for compact packaging inserts. Common for unit-dose pharmaceuticals and small device kits.
Accordion-style folding for longer documents that must fit inside a carton. Ideal for combination products and multi-language IFUs.
Saddle-stitched or glued booklets for complex instructions requiring multiple pages. Supports multi-language requirements in a single document.
High-volume roll-fed IFU production for automated insertion into packaging lines. Available for larger production runs.
Signed CoC confirming the IFU meets all specified dimensional and print requirements.
Version-controlled record of all artwork approvals — critical for 510(k) submissions and technical files.
Full production record with lot number and materials traceability for every IFU run.
Dimensional and print quality inspection results against approved specifications.
Package inserts and patient information leaflets for Rx and OTC drug products under 21 CFR Part 211.
Instructions for Use for Class I, II, and III devices — formatted to meet IEC 82079-1 and ISO 15223 symbol requirements.
Multi-language IFU inserts for in vitro diagnostic kits, including rapid test and point-of-care formats.
IFUs for drug-device combination products requiring coordinated labeling across both regulatory pathways.
Submit your format, dimensions, and quantity. We'll turn around a quote within one business day.