Best Practices for Medical Device IFU Packaging and Shipping

For device labeling managers overseeing medical device documentation, proper packaging of Instructions for Use (IFUs) can mean the difference between smooth distribution and costly rejections. As a specialized medical device IFU printer, Kase Printing has developed comprehensive processes that ensure your documentation arrives pristine and ready for use, meeting both FDA requirements and ISO standards. We share some of those processes here.

Understanding IFU Medical Device Packaging Requirements

Quality control for medical device IFUs starts well before printing the first document. At Kase Printing, each project begins with a systematic approach to quality management that tracks every production stage through final delivery.

“Our process relies on what we call a ‘traveler sheet’,” explains Mike Ribaudo of Kase Printing. “It’s a comprehensive quality control document that follows each IFU project through every production stage. Every department manager is part of a chain, starting with planning and following through each manager until the IFU project leaves our facility. Fred generates the production ticket and quality control traveler, putting it into a job jacket along with the printed samples or printed proofs. From there, it moves through each department, where people pull it out, sign off on it, and put it back in the job jacket.”

The traveler sheet serves as a detailed, extensive checklist that requires verification at every production stage. Department managers must check off items such as: ensuring folds are properly aligned, verifying panel placement, checking for any imperfections, and confirming proper bundle quantities are per the work order. Each stage requires manager signatures, creating a complete record of the production run.

“We have to document in some meaningful form what we do every day,” Ribaudo notes. “It’s documenting the processes that we all think, do, and know like the back of our hand. Our customers need them to be written down, saved, and traceable per project production lot. When an auditor comes in, we need to be able to go to a file, find that particular print run, pull it out, open it up, and have the documentation provide the whole story.”

This systematic approach to quality control has helped Kase Printing pass rigorous audits from major medical device manufacturers, even without formal ISO certification. Their documentation process proves particularly valuable for medical device companies that need to meet strict FDA and EU MDR requirements for supplier management as part of their quality management system (QMS).

Clean Room Standards and Particulate Control

For medical device manufacturers, maintaining pristine documentation isn’t just about print quality – it’s about ensuring safe and effective use of medical devices through proper packaging standards. Kase Printing maintains strict cleanliness protocols throughout the entire production process.

“When dealing with clean room environments,” notes Ribaudo, “every detail matters. Something as simple as an infrequent stray mark or particulate found on IFU product can trigger a rejection. That’s why we implement plastic-lined boxes for particulate control and maintain rigorous environmental monitoring throughout the process.”

Packaging Standards for Complex Requirements

Medical device IFUs present unique challenges that require specialized solutions. One of the most critical aspects is paper selection and management. “Our most commonly used IFU stock is 40-pound paper,” Ribaudo explains. “When packaging an IFU with medical devices, you have to think about the space it takes up in the box and shipping weight. Every bit of extra thickness or weight in your IFU means less space for product and higher distribution costs.”

The challenge becomes even more complex when dealing with international requirements. “When you want to sell your product in the European Union,” Ribaudo points out, “you really need to supply a printed IFU in every European Union market or language in which your product is going to sell.” This often means managing up to 19 different languages.

 

Environmental Controls and Quality Management

Seasonal changes and environmental factors are essential in IFU production and packaging. “Folding IFUs in the summer versus folding IFUs in the winter… that’s a factor that needs a strategy,” Ribaudo shares. “There’s a different moisture level in the air, in the paper. You can get static buildup in the operating equipment.”

To combat these challenges, Kase Printing implements comprehensive environmental controls, including:

• Temperature and humidity monitoring
• Seasonal adjustment protocols
• Specialized folding techniques
• Regular equipment calibration

Shipping Integrity and Quality Verification for IFUs

The final stage of quality control focuses on shipping integrity, where even minor imperfections can lead to major issues. “If you have a pen-hole-size hole in a carton, they will likely reject the whole carton,” warns Ribaudo. “They don’t know what’s in there, and they don’t know what could have gotten in there during transit.”

Each shipment undergoes rigorous quality control checks before leaving the facility. Documentation includes production lot identification, quality control records check, COC generation and proper shipment labeling approval. This attention to detail ensures that IFUs arrive in perfect condition and are ready for distribution with their corresponding medical devices.

Moving Forward with Best Practices and Confidence

For medical device manufacturers navigating the complexities of IFU packaging and shipping, success depends on working with experienced partners who understand both regulatory requirements and practical implementation. Kase Printing brings decades of experience in medical device documentation, helping production managers ensure their IFUs meet all requirements while maintaining the highest quality standards.

Contact Us for Your Instructions for Use!

Looking to streamline your IFU production and packaging process? Our team understands your challenges and can help implement solutions that work for your unique needs. Contact us to discuss how we can help ensure your medical device labeling documentation meets your packaging requirements while maintaining the highest quality standards throughout the print production process. We are here to work with you and your team!