Meet and Greet Keith Morel at the International Conference on Medical Device Risk Management hosted by the INCOSE Healthcare Working Group

Date: 22 April, 2024

Location: Medtronic OHQ in Minneapolis, MN, USA

Intoduction

Join Keith Morel during the event for the following session:

• Justifying criteria for risk acceptability - challenges with synthesizing various sources of data. Typically a Severity (of Harm) ranking and a Probability of Harm (p[Harm]) ranking are used to estimate risk. Often a risk chart is used to define regions by magnitude of residual risk as an approach to risk control, which is also part of the risk acceptability criteria.
  
  This discussion will explore methods to justify p(Harm) ranking based on available data and analysis (including some of the challenges of synthesizing data from clinical investigations, literature and PMS to come up with consistent and reliable p(Harm) estimates - which often give wildly different estimates).

For more information about the event and to order tickets, please visit the event website.

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