Posts

Risk Management: learn from my mistakes

/in , /by
This article is about Risk Management applied to a medical device I co-invented and commercialized in 2004. I followed it’s history after our company was acquired, and am re-analyzing our 2004 work using lessons learned in 15 years.

I describe that product in another article. This article helps you learn from my mistakes.

Read more

Take this quiz to see if you’re ready for MDSAP

/in /by
3 minute read, or a 12 minute quiz, if you’re ready.

By January 2019, the Canadian government will require all companies selling medical devices in Canada to be certified under the Medical Device Single Audit Program (MDSAP). If you’re familiar with MDSAP, this article quizzes your knowledge of key concepts. If it’s new to you, read how to prepare for MDSAP.

Read more

How to apply Risk Management

/in , , /by
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.

Read more