White Papers

Regulatory Considerations for the Medical Industry

By Heidi
Regulatory Whitepaper - Harpak-ULMA

Regulatory Considerations in Medical Device Packaging Whitepaper

Healthcare costs have skyrocketed, making packaging of volume-driven Class I and Class II medical devices such as syringes, intravenous (IV) administration kits and catheters, a target for cost and risk containment.  Packaging helps ensure devices are delivered contaminant-free, safe to use, and able to withstand a wide range of shipping and storage conditions. While packaging and sterilization are mostly technologies that rely on proven methods, the emergence of smaller, more complex devices and kits combined with cutting-edge barrier materials and flexible films is challenging the status quo of legacy packaging solutions.

Download to Learn More About: 

  • Regulatory Environments
  • Sterile Packaging Requirements
  • Packaging System Process Validation