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Medical Package Testing

Shelf Life Isn’t a Fixed Number: How to Rethink Accelerated Aging and Real-Time Data

Too often, shelf life is treated like a fixed, static number printed on a label—the inevitable result of a formula, test, or aging chamber. But for medical device manufacturers, shelf life is a claim that must be defended.
Technician in a cleanroom writing compliance documentation while wearing protective gear, including gloves, a mask, and a hairnet.

Navigating the Future of Quality: What AI-Enabled QMS Means for Medical Device Startups

The promise of AI and digital transformation in quality management is everywhere, especially in the medical device space. From investor pitches to thought leadership blogs, there’s growing excitement around the potential of AI-enabled eQMS platforms to replace outdated, document-heavy systems with real-time, data-driven, automated intelligence. Two recent articles, “The Future of Medical Device QMS” and “The Digital Revolution in Medical Technology,” explore this evol
LSO Medical Package Testing
Medical Package Testing

Realistic Worst Case Configurations: Why Regulatory Justification Is Harder Than the Test Itself

Learn how a Realistic Worst Case (RWC) configuration impacts your medical package testing and influences regulatory evaluations.

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