Training: In-person
Date: 13 October 2023
Time: 9:00 - 17:00 CEST
Price: € 699,-
Location: Novotel Amsterdam Schiphol Airport | Amsterdam, the Netherlands
Introduction:
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
Trainers: