medical device reporting Posts

eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

eMDR and UDI AS2 Gateway Messaging: Be Aware of Unintended Consequences

Bernard Jee, Product Manager, Pilgrim Quality Solutions

Keeping on top of regulatory updates is an ongoing challenge. Regulatory bodies are constantly making updates and Life Sciences organizations are expected to interpret these guidelines and fold them into their existing quality and compliance systems. We’re all aware that the cost of misinterpreting or ignoring these updates is high. That’s why it’s important not only to monitor these updates, but also to closely examine them for unintended consequences to the rest of your quality and regulatory processes. In this post, we’ll examine a recent update to FDA electronic submissions and shine a light on some unintended consequences and potential missed communication from this update.
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