Reduce Risk As Far As Possible
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.
Entries by jasonpartin
How to apply Risk Management
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.
The MDR big picture
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.
Time is valuable; write concisely.
Sixty-three words that could change the world are:
The risk of being biased
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.
Why I practice writing
Writing deepens my understanding of a topic, and can help other people. It’s a form of meditation, to see something clearly through concentration and analysis.
IIb, or not IIb: that is the question for the European Union Medical Device Regulation
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
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.
Truth Prevails
8 minute read. These are the lasting impressions of 30 books I read while backpacking across Nepal and India. The trip took 2 1/2 months; this summary takes a few minutes at the average reading rate of adults. Books in English were rare treats shared between travelers, a chance to learn from other people including […]