Module 14 2022

TD Submissions - Remember to Include:  Information to allow the design stages applied to the device to be understood  Design Specifications or Design Inputs, etc.  All Process Validations and associated Validation Plan  Risk Management Plan  Clinical Evaluation Plan as well as Clinical Evaluation Report  Device-specific PMS Plan and PMCF Plan (if applicable) including proactive elements  Incoming, in-process and final inspection checks and the results New requirements compared to MDD/AIMDD or often missed

The Organisation for Professionals in Regulatory Affairs