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Technical resources and guides focused on maintaining industry standards, including ISO 11607 and FDA requirements, to ensure medical device packaging meets legal safety and shelf-life benchmarks.

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Compliance & Standards

Medical Device Packaging Shelf Life: A Guide to ISO 11607 & FDA Compliance

February 27, 2026 Van Der Stahl Scientific No comments yet

Medical device packaging shelf life is a critical component of patient safety and regulatory compliance. A sterile barrier system must maintain integrity from the moment it is sealed through sterilization, distribution, storage, and ultimately to the point of use. ISO 11607 and FDA guidance define the framework for proving that your packaging system can reliably […]

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