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Gaining True Information Flow
MES/MOM users are more likely to improve core business performance. Figure 1 of Information Flow for Agility, Compliance and Performance in Project Manufacturing. Since I started in the manufacturing...
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UDI: Medical Device Profits at Risk – Unnecessarily
Traceability for containing issues and UDI compliance is an ongoing cycle. How many companies’ profit margins will plummet because of the FDA’s Unique Device Identifier (UDI) requirements? Quite a few,...
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Can Track & Trace improve profits?
Everyone wants to have lower costs and improve their efficiency and effectiveness at the same time. Fortunately it’s increasingly possible to find approaches to do just that. As companies move from...
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Benefits beyond the “have to”
Complying with a regulation or “have to” can lead to benefits that more than offset the burden of change. Nearly everyone has “have to” or “should in their vocabulary, and feels there are things that...
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Realities for UDI and Beyond
UDI Lessons Learned Webcast with Jay Crowley and Cathi Crist was a revealing look at what companies need to do The #1 concern that keeps medical device professionals awake at night is compliance with...
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Can you See the Silver Lining in Compliance?
When you see clouds, do you see the silver lining as well? Compliance can be an opportunity. The old adage is “every cloud has a silver lining.” Finding the positive in what is typically considered a...
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Re-framing in Medical Devices
Regulations – such a burden on the medical device industry. Or are they? I am advocating that companies Can you see the opportunity or just the burden of regulation? This is just one example from eDHR....
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