7 Critical Factors for IFU Instructions for Use That Could Make or Break Your Medical Device Launch

Manufacturing medical devices require precise attention to detail, but the Directions for Use (DFU) or Instructions for Use (IFU) that accompany these devices are equally critical for safe and effective use. As a device labeling manager overseeing medical device documentation, you know that one quality control slip in your IFU printing process could lead to serious consequences.

Building a Foundation With a Quality Management System

Quality management isn’t just about checking boxes—it’s about ensuring patient safety and meeting FDA requirements for medical devices. A robust quality management system (QMS) is the backbone of creating and providing successful printing services to device labeling managers overseeing medical device IFUs.

When it comes to printing Instructions for Use for medical devices, quality control goes far beyond basic print inspections. The printing process itself requires a carefully orchestrated system of checks and balances, with every step documented and verified. Understanding this quality management system is critical for device labeling managers seeking a reliable IFU printer.

“Every department manager is part of a single chain,” explains Mike Ribaudo of Kase Printing. “It starts with our planning team generating the production ticket and the quality control traveler that follows the job through every stage of production.”

One of the key tools in this quality management process is what’s known in the industry as a “traveler sheet”—a comprehensive quality control document that accompanies each IFU project from start to finish. At Kase Printing, this traveler is more than just a checklist; it’s a detailed, extensive quality control document that requires signoffs at every production stage.

“The traveler sheet follows the job through every department,” Ribaudo explains. “People pull it out, sign off on it, put it back in, and it moves along. Every stage—from order planning to final packaging—must be documented and verified. If someone skips a step or misses a signature, we catch it immediately and can address it before it becomes an issue.”

This systematic approach means:

• Every production step is documented and traceable
• Department managers are accountable for their stage of production
• Quality issues of non-conforming materials can be addressed promptly
• A complete record exists for every production run

The Critical Role of Documentation

A comprehensive quality management system (QMS) for medical device labeling must include:

• Documented procedures for each production stage
• Clear accountability for quality checks
• Traceability throughout the process
• Meet document archival requirements

“Everything needs to be traceable, trackable, per the project production lot,” Ribaudo emphasizes. “You’ve got to be able to go to a file, find that particular print run, pull it out, open it up, and let the documentation set tell the whole story.”

1. Pre-Press Design Requirements

When creating instructions for use for medical devices, the pre-press stages of design is where FDA compliance comes into view. The FDA requires manufacturers to ensure that all labeling meets specific standards for readability and accuracy.

Font and Layout Standards

For safe and effective product use, your IFU must maintain:

• Minimum 6-point font size (6.5 point, 7 point, and 8-point fonts are typical)
• Clear hierarchy of information
• Appropriate margins and space allowance for folding
• No screened type for maximum ink density

“We print at 200 lines per inch resolution with closed-loop color and ink density control,” notes Ribaudo. “That matters for readability and final product consistency.”

2. The Paper Factor That Medical Device Manufacturers Often Overlook

Regarding medical device labeling requirements, paper selection isn’t just about cost—it’s about ensuring the safe and effective use of your product while minimizing packaging impact. For medical device manufacturers, every fraction of an inch matters in product packaging design, and IFUs need to take up as little space as possible while maintaining readability. The right paper weight can make the difference between a compliant IFU and a rejected shipment or between efficient packaging and excess weight that drives up shipping costs.

“We specialize in IFU manufacturing using 40-pound paper,” Ribaudo explains. “It’s our best value IFU paper stock. When you’re packaging this with medical devices, you have to think about not only folding the IFU, but also the space it takes up in the box and its shipping weight. Every bit of extra thickness or weight in your IFU means less space for product and higher distribution costs.”

Critical Paper Considerations for Medical Device IFUs

 

For device and equipment documentation, consider the following:

• Paper weight and its impact on final folding quality
• How changes in moisture will affect acceptability
• How paper opacity and paper finish affect readability
• How bundling affects product longevity

“Folding IFUs in the summer versus folding IFUs in the winter… that’s a factor that needs a strategy,” notes Ribaudo. “There’s a different moisture level in the air, in the paper. You can get static buildup in the operating equipment at any time.”

3. The Folding Process That Makes or Breaks IFU Readability

The FDA requires manufacturers to provide clear, easy-to-understand instructions. When it comes to medical device IFUs, proper folding isn’t just about aesthetics—it’s about ensuring safe and effective product use.

Meeting Conformance Standards

Kase Printing’s expert folder operators maintain strict quality controls:

• No wrinkles affecting readability
• Precise folds between text columns
• Proper use of wet scores and paper slitting wheels
• Proper setting of roller gaps

“The quality of your soft folds determines whether the type’s going to be readable after it’s been folded and after you open it up,” Ribaudo emphasizes. “If it’s a poor-quality folder setup or adjustments are not made during the run, you will get wrinkles on the folds, and you will not be able to read the type due to the wrinkle and the IFU becomes non-conforming product.”

 

4. Particulate Control Guidelines for Medical Device Instructions for Use

Maintaining a clean environment during IFU production isn’t just good practice for medical devices and their accessories—it’s essential for meeting FDA requirements and ensuring safe use. The Food and Drug Administration has strict standards about particulate contamination, especially for devices intended for use in health care facilities.

Understanding Particulate Limits & Clean Room Standards for IFU Production

“When a customer quality samples our IFU product and they, for example, find too many particulates in their sampling, they’ll reject the whole job,” Ribaudo warns. Device labeling managers need to consider:

• Sampling regimens for quality control
• Acceptable particulate thresholds
• Documentation of cleanliness standards
• Impact on Medical Device Labeling Compliance

Clean Room Standards in Practice

The medical device industry demands pristine production environments, and this extends to IFU printing facilities. While many print shops focus solely on print quality, medical device documentation requires a higher standard of cleanliness. Even a single contaminated IFU can lead to a rejected shipment, costing both time and money. That’s why maintaining a controlled production environment is crucial for medical device documentation.

At Kase Printing, maintaining clean production environments means:

• Plastic-lined boxes for particulate control
• Regular equipment cleaning
• Environmental monitoring
• Strict handling procedures

“When you’re dealing with print product that enters clean room environments,” Ribaudo notes, “every detail matters. Something as simple as an infrequent stray mark or particulate found on IFU product can trigger a rejection.”

5. Medical Device IFU Packaging Requirements – Packaging Integrity That Protects Your Investment

For medical device manufacturers, packaging isn’t just about shipping—it’s about maintaining the integrity of your instructions for use until they reach their destination. One compromised box can lead to costly delays and compliance issues.

Protecting Instructions for Use Through Proper Packaging

“If you have a pen-hole size hole in a carton, they may reject the carton,” explains Ribaudo. “They don’t know what’s in there; they don’t know what could have gotten in there during transit.”

Key packaging considerations include:

• Box integrity verification
• Moisture barrier implementation
• Shipping protection measures
• Final quality sampling procedures

The Plastic-Lined Box Solution

While it adds a small cost, plastic-lined boxes provide essential protection:

• Prevents particulate contamination
• Maintains document integrity
• Ensures compliance with medical device regulation
• Supports effective IFU delivery

6. Final Quality Verification for Medical Device Patient Labeling

For medical device manufacturers, the final quality check isn’t just a formality—it’s their last line of defense against costly recalls and regulatory issues. Creating instructions that meet FDA requirements demands a systematic approach to final verification.

Multi-Point IFU Inspection Process

“Every time we run the job and produce the label, we print out what we call a label proof,” Ribaudo explains. “There’s a square where you stick the label on the square, and then you fill in all of the information and then you sign and date it.”

Essential verification points include:

• Physical inspection of printed materials
• Documentation completeness review
• Required COC sign offs
• Final shipment inspection

Sample Retention Requirements

Device labeling managers must ensure:

• Proper sample storage
• Documentation retention
• Traceability maintenance
• Quality record preservation

7. Implementing a Quality Management System to Meet Medical Device Quality Control Requirements

To produce consistent results, medical device labeling requires more than just good intentions, it needs a systematic approach to quality control.

Training for Effective IFU Production

Quality control success depends on:

• Experienced folder operators (5+ years recommended)
• Regular staff training
• Clear standard operating procedures
• Documented quality checks

Quality Control Tools and Templates

“We use a traveler sheet,” notes Ribaudo. “It’s an extensive checklist of everything we expect a human to check for at each stage of the project.”

Essential tools include:

• Quality control checklists
• Documentation templates
• Sampling procedures
• Non-conformance procedures

Measuring Success

For medical device IFUs, success means more than just meeting regulatory requirements—it means ensuring safe and effective use of your products. At Kase Printing, we understand the challenges device labeling managers face in maintaining quality while meeting deadlines and budgets.

Whether you’re dealing with regular IFU production or launching new medical devices, having a trusted IFU print partner with experience in medical device documentation can make all the difference. Want to learn more about how our quality control checkpoints support the QMS requirements of your IFU production process? Reach out to discuss your specific needs with our team.

Remember: Quality control isn’t just about avoiding problems, it’s about having confidence in your medical device labeling processes and ensuring patient safety through clear, legible instructions for use.