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Global compliance: Flexibility is the key

To accomplish the successful deployment of a global serialization program, flexibility is the key.

The system you ultimately put together should not be targeted at a single regulation but should be designed to provide building blocks of functionality, which can be applied differently to the same products shipped into many different regulatory environments around the globe.

Waiting for new, nonbinding guidance from the FDA is less important than recognizing the increasing number of binding regulations emerging around the world.

A key to baking in flexibility is to maintain a global regulatory “knowledge base.” GS1 Healthcare maintains an up-to-date database for access by its members. One benefit of their database is that most of the documents have already been translated into English by a professional translator.

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
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Medical Device Innovations Report
Break out of the ordinary: see what’s new in life sciences packaging
At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us this month to experience a breakthrough for life sciences products.
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Break out of the ordinary: see what’s new in life sciences packaging