Navigate Evolving Medical Device Packaging & Sterilization Regulations

October 29, 2021

Regulations surrounding medical device packaging and sterilization constantly evolve, and making matters more challenging, they vary according to the type of sterilization process the device undergoes. The complexity of these ever-changing sterile packaging requirements challenge engineers' ability to design and manufacture medical devices that meet the FDA and EU MDR's requirements safely and efficiently. And because packaging is considered an accessory to the device itself, sterile packaging is often an afterthought during the manufacturing process rather than a practice that should be integrated into the design stages.

Addressing these challenges, the Sterilization Packaging Manufacturers Council, or SPMC, consists of a group of industry leaders who work collaboratively to educate professionals on packaging and sterilization practices and how to deliver medical devices in a safe and sterile manner, ultimately, providing unparalleled patient care. Read the full article in MD+DI magazine.