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Sample Size for Medical Packaging Validation

Check out the archived “radio show” hosted by Karen Greene on the Community Blog-Medical Packaging Innovation.

During this radio show Karen Greene discusses a process for the development of a statistically valid sample size for your sterile barrier system validation. The focus is on conducting a risk assessment of your packaging design in conjunction with your medical device design and aligning it with your company’s policies on assigning criticality to packaging defects.

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