Entries by jasonpartin

How to apply ISO 14971 risk-management (it’s easier than you think)

6 minute read. In 1986 the space shuttle Challenger exploded, killing the crew and a high-school teacher that had trained with the astronauts. The explosion originated near an O-ring gasket that sealed rocket fuel. The gasket protected a known design flaw that could expose fuel to fire. NASA’s purchasing department had bought the O-ring based […]

MDR: the Medical Device Regulation formerly known as MDD

In 1993, the rock musician Prince changed his name to an unpronounceable symbol, confusing record companies, concert venues, and even fans. It turned out to be one of the most productive times of Prince’s esteemed career, releasing two albums each year during this transition. In 2020, the European Union is changing their Medical Device Directive […]

Understand the ISO process approach by using 1980’s pop-culture

Three of my skills in this world include medical device development, teaching, and 1980’s pop culture. This article combines all three, using pop culture to illustrate concepts behind medical device quality system regulations that require a “process-based approach.” It’s starts with this, which will either confuse you or make you chuckle: Was that a process? […]

Steps away from addiction

2 minute read. I define addiction as: Acknowledging an action has consequences harmful to yourself or othersAcknowledging that you’d like to stop an action, then repeating the action I took this photo in 2010 while laughing with friends after I had surgery and was diagnosed with medical conditions associated with chronic pain. By 2017 the […]

Dyslexia

6 minute read, unless you’re dyslexic, then it’s 9 19% of us have it, and so do 55% of prisoners and many celebrities. Dyslexia has many forms, and many levels, and we may not even realize we have it. What’s saddening is the correlation between dyslexia, school dropouts, and prison. 5-19% of people exhibit dyslexia35% […]