Description: The presentation will discuss approaches to meeting the Performance Evaluation Report requirements including: planning for legacy devices; identifying data gaps and potential sources of evidence; templates and SOPs that may need to be created; incorporation of post-market surveillance (PMS) data; and considerations for post-market planning.
Learning Objectives:
Identify the necessary inputs to a Performance Evaluation Report
Perform a gap assessment of existing information to meet the Performance Evaluation Report requirements.
Create or update SOPs to prepare and maintain Performance Evaluation Reports.
