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I am new to medical device packaging. Why do so many products have porous windows in their packaging even though they are not gas-sterilised?

There are legacy PVC medical device products on the EU market that have been used in large volume over at least the past three decades with, presumably, no deleterious effects. They would be expected to fail the current 10993 testing (as PVC is used as a

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Recast of MDD

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Changing business model

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Watch the archived free webcast "How to Achieve Compliance with IEC 62304 for Medical Device Software Development." Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development.

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