Date: January 21st, 2021
Time: 17:30-19:00 CET | 8:30-10am PST | 11:30am-1pm EST
Location: Virtual, Live Q & A
Join us January 21st, 2020!
December 17th event is FULL to capacity so we added another date! Limited Space. Register Now!
If you are already registered for December 17th, please join us then. We would like all to have the opportunity to attend.
Introduction: As the deadline quickly approaches for the 2nd time and the MDR continues to reinforce many of the practices and norms from ISO 14971:2019 (and EN ISO 14971:2012) and aligns well with them, it also emphasizes a few key points, such as the connection between manufacturing controls and risk management.
- Understand the connections between manufacturing controls and risk management, emphasized in MDR.
- Work through case studies of the connection between clinical data and the 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.