ABSTRACT
This chapter moves beyond product development considerations to the commercialization and post-market phase of the combination product lifecycle, referred to here as “Lifecycle Management.” Key aspects and best practices for combination product lifecycle management reviewed include: (i) Design Transfer, Process Validation/Continued Process Verification expectations and considerations; (ii) Change Control for Post Market Modifications; (iii) Design History File Maintenance; and (iv) Post Market Vigilance, Surveillance and Reporting. The chapter concludes with a helpful risk-based integrated framework of the closed loop combination product lifecycle and deliverables.
