Content by AssurX

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AssurX
Last month an investigative report revealed that the U.S. Food and Drug Administration (FDA) has millions of “hidden” serious injury and malfunctions reports on medical devices. According to the...
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AssurX
Proposed in 2012 and now in effect, the general data protection regulation (GDPR) is the newest landmark of data protection legislation. GDPR compliance legislation is designed to better...
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AssurX
When a change management system is designed effectively, it defines how strategies, procedures, and technologies will be applied to address changes in the business environment. Implementing a...
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AssurX
Recent FDA warning letters indicate that many drug manufacturers do not have their manufacturing in a state of current good manufacturing practices (CGMPs) control. During the first half of 2017,...
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AssurX
Three recent warning letters from the Center for Device and Radiological Health (CDRH) offer a glimpse into ongoing medical-device inspection investigative focus. CAPA noncompliance is a top...
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AssurX
The Advanced Medical Technology Association (AdvaMed) wants the U.S. Food and Drug Administration (FDA) to understand that medical device manufacturers need clarity on the FDA’s heightened focus on...
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AssurX
The FDA’s Center for Devices and Radiological Health (CDRH) provided a glowing self-assessment in a recent report. The CDRH met its 2016 strategic objectives for several initiatives pertaining to...
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AssurX
A common pitfall in quality management system (QMS) process automation occurs with a poorly planned process automation strategy. Too often, the temptation is to automate all quality processes at...
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AssurX
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. In December 2016, Director Janet Woodcock laid out some of the...
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AssurX
If compliance with the North American Electric Reliability Corp. (NERC) Reliability Standards wasn’t complex enough, registered utilities must also factor in the regulatory nuances of the bulk power...