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Session 5: Post-Market Stage of the Product Lifecycle
Session Chair(s)
Jonathan Amaya-Hodges
Senior Principal Consultant
United States
Risk Management is an ongoing and iterative process, inclusive of the post-market stage of the product lifecycle, which is of growing importance to medical products as highlighted by additions to ISO 14971:2019 as well as initiative such as FDA’s Total Product Lifecyle (TPLC) approach. Combination products pose unique challenges in post-market risk management, given divergent needs and requirements of the constituent parts and their respective data sources. This session will discuss how a manufacturer may bring together a cohesive and holistic post-market risk management process for combination products.
Learning Objective : - Describe basic post-market risk management principles as they apply to individual medical devices and drugs/biologics
- Describe how post-market risk management expectations converge for combination products
- Create a strategy for a holistic post-market risk management process for combination products
Speaker(s)
Speaker
Jonathan Amaya-Hodges
United States
Senior Principal Consultant
Speaker
Kimberly Trautman, MS
Trautman International Services, United States
Managing Director