Tag Archives: compliance
Re-Frame medical device DHR Product data

Re-framing in Medical Devices

Regulations – such a burden on the medical device industry. Or are they? I am advocating that companies re-frame traceability regulations to see them as opportunities. Whether it’s eDHR or UDI, these requirements are actually proving to have an enormous upside, and not just for patient safety. What most medical device companies have not yet […]

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Can you See the Silver Lining in Compliance?

The old adage is “every cloud has a silver lining.” Finding the positive in what is typically considered a negative can be powerful.  Can you do it with compliance? Most manufacturers rebel against compliance requirements.  Whether the demand for compliance is from a customer or a regulatory body, if the company views it only as […]

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Realities for UDI and Beyond

The #1 concern that keeps medical device professionals awake at night is compliance with new regulations. The question is, how much work will medical device companies need to do to meet the FDA’s Unique Device Identifier (UDI) requirement? Most companies will need to do quite a lot that they haven’t until now. So is it […]

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Benefits beyond the “have to”

Nearly everyone has “have to” or “should in their vocabulary, and feels there are things that fall into those mandatory categories. For individuals that might be spending time with difficult family members, getting regular exercise, and paying taxes. For manufacturing companies, much of that is regulatory or customer compliance. We often feel these as major […]

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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 manual, compliance-oriented views of traceability and genealogy to more automated and improvement-oriented perspectives, they are finding what formerly seemed impossible: better ways to operate […]

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UDI: Medical Device Profits at Risk – Unnecessarily

How many companies’ profit margins will plummet because of the FDA’s Unique Device Identifier (UDI) requirements? Quite a few, I imagine. Don’t get me wrong. I am not opposed to the regulation. I think it makes sense, and that companies will comply. The question is: at what cost? I believe it is possible to comply […]

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Gaining True Information Flow

Since I started in the manufacturing industry over 25 years ago, the vision of integrated information systems has been central – and finally some companies are striving to offer solutions that provide that flow. We have always known it could improve agility to have at  core enterprise and plant floor functions integrated. In addition to […]

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