Shelf-life Verification Guide
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Use this Shelf-life Verification Guide template to plan and document the necessary testing for medical device shelf-life claims, covering both accelerated and real-time aging methods to ensure packaging and device integrity over the intended storage period. Complete this guide before engaging a contract laboratory, as it helps define the testing approach, intervals, and required outcomes for regulatory compliance. Fill out this document when you need to establish or validate the expiration date of your medical device as part of your technical documentation or regulatory submission.