Van Halen, Brown M&Ms, and Quality Assurance

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6 minute read.

In the 1980’s, the rock-band Van Halen caused $85,000 damage to their dressing room after finding brown M&M’s in their bowl of “munchies” before a concert. The facts behind that story can help medical-device companies become more efficient and pass any FDA or ISO Quality-System audit. This article shows you how, with the lead singer of Van Halen, David Lee Roth, as your guide.

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Reduce Risk As Far As Possible

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In 1987, the hip-hop group Public Enemy asked: “How low can you go?” In 2017, Europe responded, “As Far As Possible.” This article discusses how to reduce medical device risks as low as possible.

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How to apply Risk Management

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6 minute read.

In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts. In this article, I travel back in time to reanalyze the Space Shuttle program using modern methods for Risk Management.

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The MDR Big Picture

The MDR big picture

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7 minute read.

Any company that wants to sell medical devices in the European Union must follow new EU Medical Device Regulations. These new regulations were motivated by EU citizens demanding safer healthcare. This article is the EU-MDR big picture with links to learn more. Read more

Time is valuable; write concisely.

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Sixty-three words that could change the world are:

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The risk of being biased

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3 minute read.
 
Teams resist change because of biases, our tendency to form opinions based on incomplete or inaccurate information. This article explains the nature of our biases and why we resist new regulations in healthcare safety, but the concepts apply to all of us.

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Why I practice writing

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I enjoy learning while teaching complex concepts, so I’m learning to improve my communications skills while writing a blog, using topics I enjoy as analogies to concepts in my work. If you’re reading this, please consider skipping it because it’s a work in progress and may not be worth your time.

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IIb, or not IIb: that is the question for the European Union Medical Device Regulation

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Work in progress, please don’t forward, and please consider reading other articles first.
6 minute read.

Learn the EU-MDR Unique Device Identifier System from Voltron

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6 minute read.
Life should be fun, and I try to find ways to bring fun into work. This article uses Voltron, Defender of the Universe, to teach the European Union Medical Device Regulations requirements for Unique Device Identifiers.

My Auto-signature: Cuba!

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