Regulatory Compliant IFU Inserts for Medical Device and Pharmaceutical Firms

If you’re in the medical device or pharmaceutical industry, you are under a lot of scrutiny. 

The Federal Drug Administration (FDA) and other regulatory agencies place many demands on your product development and manufacturing process.

And that includes product package inserts.

IFU (Instructions for Use) Package Inserts
Every medical device and pharmaceutical product must provide their customers with detailed instructions for the use of the product.  This may also include instructions for cleaning the product.

Instructions may be short or long depending on the complexity of the product.

​Instructions may also need to be adapted to different audiences (consumers, medical professionals) and different languages.

Starburst meets ISO 9001 standards

Consistent with its ISO 9001: 2015 quality certification, Starburst has the production procedures and controls in place to meet the strict guidelines for printing and folding/bindery/finishing services of IFU package inserts. 

​These guidelines call for 100% defect-free print quality with tight tolerances for finished size, thickness and weight. 

A one-stop printing solution for IFU inserts

Starburst Printing & Graphics works with medical device and pharmaceutical manufacturers in the production of IFU (Instructions for Use) package inserts.  

With a full range of offset and digital printing equipment, Starburst is positioned to serve the regulatory printing requirements of these firms.

Flexible print and finishing solutions
To satisfy regulators, design teams and supply chain managers at medical device and pharmaceutical manufacturers must turn to professional printing companies that can provide:
  • Complete printing and finishing services for a wide range of formats
  • Access to both digital and offset printing
  • Ability to customize and be innovative
  • Flexibility to adjust specifications on the fly
  • Understanding of regulatory needs
  • Built-in methodologies to document process and records
  • Adherence to quantity requirements with minimum overruns

Print on Demand inventory controls
Print-on-Demand (POD) combines print technology (digital and offset) with print inventory management to give customers the ability to more effectively manage their ongoing printing needs.

POD is an important service to medical device/pharmaceutical customers with multiple IFU print projects that need to be regularly updated, scheduled and ordered to precise quantities. Starburst works closely with customer teams to anticipate demand, review inventory, schedule new and repeat print orders, maintain artwork, manage print costs and provide ongoing updates and communications. 

FREE Review of your IFU and POD process
Let us show you how Print on Demand (POD) can work hand-in-hand with your IFU (Instructions for Use) insert printing needs.  POD combines print technology with print inventory management to meet the strict regulatory requirements of IFU insert printing. 

Let's schedule a FREE Review of your IFU and POD process.  There's no obligation but it will give us a chance to get acquainted and learn about your own print management requirements.  Call 800-244-8396 to schedule your review.