Industry Trends

MedTechDive — Why medical device companies are worried about the EPA’s planned sterilization regs

The folks at MedTechDive put together an easy to understand update on the EO environmental crisis, a timeline of same, and how the EPA and FDA view the problem going forward.

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E-Beam Irradiation for Cold-Chain Products: A Fast, Controlled Solution

Maintaining the integrity of cold-chain items (those that must remain refrigerated or frozen throughout storage and distribution) is a critical challenge for food safety, pharmaceuticals, and certain...

Changing Sterilization Modalities and Sterilizers for Global Products

When do I need to notify authorities or get approvals and how long does this take? A gratuitous disclaimer up front: we at NextBeam are not regulatory experts. However, we are periodically asked by...

ISO 11137-1:2025 Update Brings Major Changes to Radiation Sterilization Standard

ISO 11137-1:2025 has officially been published, marking the first update since 2006. The changes are far-reaching and impactful, reflecting the evolving needs of the medical device industry—while also...