Entries by jasonpartin

The MDR big picture

7 minute read. The new European Medical Device Regulation will be required for all medical devices sold in the EU. This was motivated by European citizens demanding safer healthcare; the United States is considering similar changes. This article is the EU-MDR big picture with links to learn more. WHY Almost 400,000 people received toxic implants […]

How to reduce risk As Far As Possible

In 1987 Chuck D, frontman of the hip-hop group Public Enemy, asked: “How low can you go?” In 2017 Europe responded: “As Far As Possible.” The new European Union Medical Device Regulation entered into effect in 2017 and will require devices to reduce risk As Far As Possible by 2020. Noncomplying devices will be removed […]

Hiking over the Himalayas helped me…

I hiked over one of the world’s highest mountain passes in a four-week journey, offline, without plans. This blog describes people I met, life in the Himalayas, altitude sickness (and rescues), and methods I used to develop mindfulness that allowed me to overcome a decade of suffering from chronic pain. It began in the town […]

You get what you give in Varanasi India

7 minute read if you skip the bad stuff. Varanasi tested my patience, humor, and immune system more than anywhere in the world. The Lonely Planet guide to India, the gold-standard of travel guides, a bible for budget backpackers, and usually a kind voice encouraging you to travel without judgement, said: Brace yourself. You’re about […]

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 […]