Risk Management…

… Two words that can elicit impassioned debate and sharp disagreement within an organisation, even with ISO 14971 in place to help!

We’ve been working closely over the past year with some of the world’s largest players in healthcare (and some of the smallest too) on just this subject.  Unsurprisingly, each organisation nneds a different flavoured way to identify, evaluate and control risks during development.  Now comes an opportunity to both share our (anonymised) experiences and learn from others in the field, as I (Matthew) get together with industry peers, AAMI and FDA later on this month at a Risk Management Summit in Washington DC.

The goals of the summit include:

  • Build a shared perspective on risk management among the diverse stakeholders who have roles in its application in healthcare technology
  • Identify barriers that are holding us back from that shared perspective and generate ideas for removing the obstacles.
  • Develop a shared plan for growing the discipline and practice of risk management in healthcare technology.

I’m looking forward to the summit and the opportunity to visit with friends who’ve moved to the DC area since my last trip.  If previous experience is any measure, this summit should be lively and deeply informative.

If you’re attending too, let me know, perhaps we can meet up over coffee or lunch.


We produced a summary report from our last summit meeting, let us know (hello@threecircles.eu) if you’d find a summary of the Risk Management Summit of use.