The aim of the session was to review some of the key differences/focus areas with regard to Risk Management under MDR vs MDD and to:
- Understand the connections between manufacturing controls and risk management, emphasized in MDR.
- Work through case studies of the connection between clinical data and occurrence of harm to illustrate and help develop the thought process needed to implement this in your organization.
- Discuss the potential need for, and how one might address, some of the “quantitative” risk aspects in the PMS plan, CEP, and SSCP.
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