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Session 7B Utilizing Continuous Market Feedback to Inform Future Decision Making for Your Combination Product
Session Chair(s)
Kimberly Trautman, MS
Managing Director
Trautman International Services, United States
Susan Neadle, MS
Principal Consultant and President
Combination Products Consulting Services LLC, United States
Risk Management and new regulatory expectations impact all Combination Product technical documentation and post-market surveillance files. Combination Product manufacturers should pay special attention to language around benefit-risk analysis, evaluation of overall, residual risk, and production and post-production activities. Discuss how premarket data and post-market data need to be aligned for continuous monitoring and how you can use the MedRA & IMDRF terminology and codes to bridge.
Learning Objective : - Evaluate the correlation between risk management and other post-market surveillance activities
- Discuss the relationship of human factors or usability engineering as part of design validation and risk management
- Assess post-market data to continuously update earlier risk management assumptions and living risk files
- Discuss strategies to incorporate appropriate terminologies and codes
Speaker(s)
Speaker
Kimberly Trautman, MS
Trautman International Services, United States
Managing Director
Speaker
Susan Neadle, MS
Combination Products Consulting Services LLC, United States
Principal Consultant and President