Medical device and pharmaceutical manufacturers rely on accurate, compliant documentation to meet regulatory requirements and support patient safety. Steven Label Group produces Instructions for Use (IFUs), package inserts, leaflets, outserts, and topserts designed to integrate seamlessly into your packaging and production processes.
As an ISO 13485-certified provider with extensive experience supporting regulated industries, we help manufacturers manage complex documentation requirements, including multi-language content, serialization, variable data, and space-constrained packaging. From simple folded inserts to complex documentation programs, we deliver solutions that support compliance, improve efficiency, and reduce production challenges.
Get startedAlso known as: Peel-and-apply IFU, mounted instruction sheet
The IFU arrives printed, folded, and sealed between two clear film layers with an adhesive back that you peel and apply directly to the pouch or box. Accommodates thick and oversized documents up to 192 pages, and because it mounts outside the package it may allow the IFU to be excluded from the sterilization process.
Read more >Also known as: instruction booklet, multi-language package insert/manual, user manual
Reader-friendly, saddle-stitched booklets built for large amounts of information and multi-language expansion. Large or small page counts, lightweight paper options to cut weight and cost, and secure rust-resistant stitching. Ideal when one insert must carry many languages or detailed protocols.
Read more >Also known as: quick start guide, folded leaflet, accordion-fold insert
A large flat sheet that folds down compactly for insertion, giving readers a single wide reading surface. Well suited to multi-language content and high information density while folding small enough to fit the carton or pouch.
Read more >Also known as: micro-fold leaflet, miniature pharma insert
Miniature folds that reach as small as 3/4″ square with up to 190 panels, using lightweight papers and specialized folding equipment. Glued or unglued to your spec. The right answer when a very small device or pharma product still needs a full, multi-language document.
Read more >Also known as: serialized insert, pharma topsert / outsert
A pharmaceutical insert that pairs patient-facing instructions with unit-level serialization, connecting the printed leaflet to track-and-trace and authentication. Multi-language ready, with lightweight paper and customized layouts.
Read more >flyers and product inserts, plus kitting and bundling to assemble multiple IFUs and components into one banded or shrink-wrapped package.
We design IFUs and inserts with regulatory compliance, clarity, and ease of use in mind. As an ISO 13485 certified supplier, we help your documentation align with your quality system and support requirements such as FDA UDI and EU MDR, while keeping content readable for patients and clinicians.
From compact micro-folds for the smallest devices to multi-page booklets for complex protocols, we match format to content and packaging. Customized layouts maximize usable space and lower cost, and every job includes a personalized IFU evaluation.
Booklets, map folds, mini folds, and topserts are all built to expand into multiple languages, so one well-planned insert can serve products sold across regions and markets.
We integrate IFUs smoothly for your unique needs whether that is ready to insert, or adhesive-backed to mount on the outside of a pouch. We can also fold, kit, and bundle IFUs with other printed components to simplify assembly.
Our lightweight paper options, available in 27#, 30#, and 40# stocks, combined with space-efficient layouts, help reduce material costs, inventory requirements, and package size while maintaining readability and regulatory compliance.
The right format depends on how much content you have, how many languages you need, and how much room your packaging allows:
Not sure which fits? We provide a personalized IFU evaluation to confirm the format, fold, and layout before production.
An IFU (Instructions for Use) is the required documentation that tells patients and healthcare professionals how to use a medical device safely and correctly. In pharmaceuticals, the equivalent document is usually called a package insert, patient information leaflet (PIL), or leaflet.
They serve the same purpose by communicating safe-use and regulatory information but use different terminology. Device makers say “IFU,” while pharma companies say “package insert,” “leaflet,” “outsert,” or “topsert.” Steven Label produces all of these formats.
The most common medical grade paper options: 27lb, 30lb and 40lb opaque offset paper. However, we offer completely custom solutions based on your specific needs.
Our Mini Fold IFUs fold as small as 3/4″ square while still holding up to 190 panels, making them ideal for very small devices and pharmaceutical products.
Yes. Our booklets, map folds, mini folds, and topserts are all designed for multi-language expansion, so one insert can serve multiple regions.
Depending on your unique project, page sizes are custom but can go up to 192 pages, and booklets handle large page counts. We design a custom layout around your content.
Yes. Steven Label is an ISO 13485 certified supplier, and we help keep your documentation aligned with your quality system and regulatory requirements.
In some cases, yes. An Adhesive In-Sheet mounted to the outside of a box may allow the IFU to be excluded from sterilization. We work with your custom specifications and specific packaging and validation.
Yes. Through our kitting and bundling services we combine multiple IFUs and printed materials into banded bundles, shrink-wrapped kits, or book bundles to simplify your assembly.
Ready to get started? Fill out our quick online form and our team will reach out with next steps. We look forward to connecting with you.