• Supply Chain Risk Management: An Ever-Changing Mosaic

    19 September, 2017 Geary W. Sikich, Principal, Logical Management Systems Corp.

    We have recognized the need to better manage supply chain risks for the nearly two decades now. Yet, we still seem to be deluded into thinking that the modern supply chain is resilient to the point of invulnerability.

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  • The #1 Cause of Medical Device Recalls—and How to Avoid It

    8 March, 2016 Lisa Weeks, MasterControl Communications

    Would it surprise you to learn that the most common cause of medical device recall, according to the FDA, is software design failure? It shouldn’t. These days, it’s hard to find a device that doesn’t rely on the use of sophisticated software to operate. What’s more, a defective software component is often harder to detect than, let’s say, a defective electrical component. It really is the perfect recipe for design disaster, but it doesn’t have to be—if you know how to use risk.

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  • Can’t-Miss Tips for Exposing Risk during Medical Device Development

    7 April, 2016 Lisa Weeks, MasterControl Communications

    Do you confuse risk analysis with risk assessment? Do you struggle to distinguish between a hazard and harm? Does the term risk management strike fear into your heart? If so, you’re not alone. Despite the publication of ISO 14971 in 2000 and, more recently, the inclusion of risk-based thinking among ISO 9001:2015 and ISO 13485:2016 requirements, many device manufacturers still struggle to understand, identify, assess and track risk across the product development lifecycle.

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  • Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

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