Open Training: Challenges of Risk Management under MDR

October 13, 2023

Training: In-person

Date: 13 October 2023

Time: 9:00 - 17:00 CEST

Price: € 699,-

Location: Novotel Amsterdam Schiphol Airport | Amsterdam, the Netherlands


The challenges discussed will include disclosure of residual risk, defining “As Far As Possible”, developing a compliant policy for risk acceptability, justifying criteria for risk acceptability, how to define indicators and threshold values for benefit-risk, justifying the specific and measurable clinical outcomes, and disclosing quantitative risks in SSCPs/SSPs for a variety of medical devices.

Key topics that will be discussed during the training:

  • Gap analyses of changes from ISO 14971:2007 versus ISO 14971:2019, EN ISO 14971:2012 versus EN ISO 14971:2019 and MDR versus EN ISO 14971:2019 related to risk management
  • Developing a compliant policy for risk acceptability
  • Defining “As Far As Possible”
  • How to define indicators and threshold values for benefit-risk
  • Disclosure of residual risk
  • Justifying the acceptance criteria for the “specific and measurable clinical outcomes
  • Nuances and challenges of Medical Device Software risk management
  • Q&A with the trainers      


Keith Morel, PhD
Coenraad Davidsdochter, MSc
Thomas Ostermeier, MSc
Post date: July 11, 2023
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