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.
Entries by jasonpartin
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 […]
Mindful meditation for pain relief
7 minute read. Meditation and mindfulness reduce suffering from pain. The United States Veterans Administration advocates mindful awareness, a process each person must follow until finding what works for their unique situation. Many books and online resources are available to help your process; here’s what worked for me, I hope it helps you.
Hiking over the Himalaya Mountains
I hiked over one of the world’s highest mountain passes in a four-week journey, part of a three-month backpacking trip through Nepal and India. This blog describes the hike, some of the people I met and their life in the Himalayas, altitude sickness and helicopter rescues, and methods I used to complete the trek without […]
What the Buddha Taught
This is a summary of What the Buddha Taught, a book published in 1959 by Walpola Sri Rahula based on historical records and original texts. I refer to it in several articles about traveling through Buddhist countries and in articles about public health, especially mindful meditation to relieve chronic pain, so I thought it would […]
Workshop Rules
I have two rules in my workshops: don’t smoke, and put away cell phones, tablets, and laptops. No one questions the first rule, but many professionals want to keep their electronic devices for multitasking during workshops. I created this blog to provide an analogy to smoking that I hope helps people see the benefits of […]
How to make state of the art medical devices
7 minute read. Beginning in 2020 the new European Union Medical Device Regulation will protect patient safety by requiring healthcare companies to make products that are “state of the art,” a term that’s often misunderstood by both companies and patients. It does not mean the latest technology, it means the most commonly agreed upon technology, […]
How to make medical devices safely and efficiently using process controls
In the film Wolf of Wall Street Leonardo DiCaprio challenged his team to “sell me this pen,” implying that a good salesperson could sell anything. In a previous article I shared how to design anything using Design Controls, and the article you’re reading now is how to “make this pen” using Manufacturing Controls. Design Controls […]