GxP Lifeline Newsletter
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January | 2019
MasterControl GxP Lifeline

Death by Risk-Based Approach: The Practical Guide to the ISO 13485:2016 Practical Guide, Part 3
by Michelle Lott, Principal and Founder, Lean RAQA Systems, LLC

 

In the last installment, we left off at, “The Practical Guide has told us where the risk-based approach applies (everywhere), but we’re all still wondering what it actually is."

 

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Software as a Medical Device: What Does It Mean and Why Should I Care?
by Mike Rigert, Staff Writer, MasterControl

 

A little over a year ago, the U.S. Federal Drug Administration (FDA) released its draft guidance (1) regarding a newer, skyrocketing segment of the medical device industry—that of Software as a Medical Device (SaMD).

 

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Medtech Startups: How to Survive Cutthroat Competition
by Matthew M. Lowe, Executive Vice President, MasterControl

 

In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years.

 

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Review the Top 5 Trends of 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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