GxP Lifeline Newsletter
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April | 2018
MasterControl GxP Lifeline

Top 5 Trends That Will Shape the Medical Device Industry in 2018
by David Jensen, Staff Writer, MasterControl

 

At the beginning of each year, it’s intriguing to look into a crystal ball to get a glimpse of what the upcoming year will look like. Given how fast technology evolves, if you so much as blink you could miss out on critical insight regarding some new trends.

 

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What, No Installation Records?
by Christopher Joseph Devine, Ph.D., President, Devine Guidance International

 

Violation of §820.170 (Installation) is one of the seldom-cited violations of the quality system regulation, in Dr. D’s (Christopher J. Devine) humble opinion, of course. The doctor believes it is just common sense to think that all activities associated with the installation of medical equipment should probably be documented.

 

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LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement
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A Force for Change: Millennials
by Craig Morgan, Head of Marketing, goBalto

 

Much has been written about the generational group, millennials, and their impact on the workplace, leadership style and corporate culture. And justifiably so, as millennials by 2025 will make up the majority of the workforce.

 

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Complaint Analysis: Don’t Forget the Work You’ve Already Done
by Jake Walton, Corporate Operations Quality Manager, MasterControl

 

There are many areas of the quality system where significant analysis work has already been done during the pre-market phase. The answers to many post-market questions are often already written in the pre-market data.

 

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GDPR Deadline Approaches: What is Expected for Compliance?
by Dave Jensen, Staff Writer, MasterControl

 

First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

 

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