As a leader in the printing industry for medical device instructions for use and pharmaceutical IFUs, we understand the strict regulatory requirements and quality standards demanded by the FDA. Our state-of-the-art printing equipment and dedicated quality assurance team ensure your IFUs meet all compliance standards while remaining easy to read and cost-effective.

Printed Materials Excellence
Our commitment to quality begins with superior materials and exacting standards for every printed piece. Your IFU printing services will benefit from our rigorous quality control process that guarantees clean, defect-free sheets that maintain their integrity throughout their lifecycle. We ensure every printed material meets the strict regulatory requirements for medical device manufacturers and pharmaceutical companies, with particular attention to clarity, readability, and durability.
Quality Assurance Standards
for IFU Inserts
Quality control is paramount when it comes to medical device IFUs and pharmaceutical
package inserts. Kase Printing's facility maintains full documentation of every production run, providing detailed tracking from initial file upload through final delivery. Each shipment includes a comprehensive certificate of compliance, complete with supplier lot numbers, carton counts, and client part numbers, ensuring transparent supply chain management and regulatory compliance.

IFU Printing Services Specifications
Working closely with our dedicated quality assurance team, we maintain precise specifications to ensure the highest standards for your IFUs and package inserts. Our state-of-the-art printing solution delivers:

Advanced Folding Capabilities
Our state-of-the-art folding equipment offers unparalleled precision for your IFU needs:
Understanding that medical device instructions for use and pharmaceutical package inserts often require complex folding solutions, our printing services utilize cutting-edge folding equipment to meet these demanding specifications.

Every IFU printing project benefits from our precision folding technology, which ensures consistent, repeatable results across multiple production runs. When you need to reprint an IFU or run a new order, we can access stored folding specifications from previous jobs, guaranteeing identical results every time.
This repeatable accuracy is crucial for pharmaceutical companies and medical device manufacturers, who must maintain strict regulatory requirements and dimensional tolerances while maximizing the efficient use of packaging space.
Our folding capabilities allow us to create easy-to-read, compact IFUs that comply with FDA regulations while fitting perfectly within your product packaging solutions.

Multilingual IFU Print Solution
Work closely with our team to create package inserts that serve a global audience:
Medical Device and Pharmaceutical Instructions
for Use Specifications
Our printing solution meets the highly regulated needs of your product. Regulatory Compliance Professional IFUs are printed according to federal drug administration (FDA) guidelines, ensuring:

Packaging Requirements
We maintain strict quality control through
Poly bag or sealed polywrap bundles
Properly sized, plastic lined corrugated boxes
Protected palletizing of shipping cartons
Clear labeling to meet strict labeling requirements
Supply Chain and Quality Control
Our one-stop printing facility offers:
Single Sheet Folding up to 28" x 40"
Our state-of-the-art printing services for medical device Instructions For Use accommodate large format IFU inserts that can be precisely folded to fit any product and packaging requirements.
Up to 16 Folds in One Pass
Using advanced digital printing and folding equipment, we ensure that every medical device IFU maintains readable quality even with complex folding patterns, getting the greatest return on your production investment.
Final Folded Size as Small as 2.5" x 2.5"
Perfect for pharmaceutical product packaging solutions, our precise folding capabilities
help manufacturers meet strict IFU requirements while maximizing space efficiency in the final package.39-Panel Configuration (13 across x 3 down)
Our committed to quality approach allows us to create complex clinical reference manuals and IFU instructions for use that provide detailed information to patients while maintaining FDA standards for readability.
IFU Printing Services
Compliance and Precision You Can Count On
Kase Printing delivers reliable, compliant IFU printing for medical devices and pharmaceuticals.
Frequently Asked Questions about Instructions For Use (IFU)
Interested in our IFU printing services? We've gathered a list of frequently asked questions to give you a clear understanding of our process.
Learn more about our regulatory compliance, multilingual capabilities, advanced folding options, quality assurance standards, packaging solutions, and cost estimates.
At Kase Printing, we specialize in producing IFUs for medical device manufacturers and pharmaceutical companies, ensuring they’re compliant, readable, and designed to meet your product’s unique needs.
We adhere to all FDA guidelines on readability, font size, and quality. Our quality control processes include complete, detailed traceability and a certificate of compliance shipped with every production lot to guarantee regulatory adherence.
Our standard sized IFUs come in compact sizes using our advanced folding options, fitting seamlessly into product packaging. We also produce IFUs to custom sizes and formats based on your specific requirements.
Yes, we offer multilingual printing to support global distribution. We ensure clear formatting and consistent page registration across all languages.
Our quality assurance process tracks each production run, provides defect-free sheets, and includes certificates of compliance, ensuring full transparency and consistent quality.
Turnaround times vary based on order size and complexity, but we offer expedited services with lead times as short as seven business days to meet your urgent needs.
With our advanced folding equipment, we handle intricate folding patterns, offering up to 16 folds in one pass and final folded sizes as small as 2.5" x 2.5".
We use either high-quality paper-based or synthetic-based substrates with smear-free printing inks, ensuring that IFUs remain durable and legible for their entire lifecycle.
Yes, we can provide digital or electronic IFU options, allowing you to distribute instructions in both printed and electronic formats if desired.
Costs depend on your volume, customization, and folding requirements. We’ll provide a detailed quote based on your specific needs.
We package IFUs in poly bags or polywrap bundles, place them in plastic-lined, corrugated boxes, and use clear labeling to meet our customers stringent packaging and shipping requirements.
We save and store each one of your IFU print specifications, allowing us to quickly produce reprints or revisions as your artwork undergoes the ECO process, ensuring consistent product results across orders.
Contact us today for
One-Stop Printing of IFUs
Contact us today for a free quote on your IFU printing needs. Our team will help you ensure compliance every step of the way while maximizing the greatest return on your print purchasing dollar.
We are experienced in providing users with IFUs in multiple different languages, containing the information they need to use and that manufacturers are required to provide today.