This session will delve into common non-conformities encountered during clinical evaluations and explore how technology can play a pivotal role in resolving these challenges. We will also discuss practical process adjustments made to prevent the recurrence of these non-conformities in subsequent reviews. Gain insights into the practical application of technology to address regulatory hurdles and improve submission outcomes.
Learning Objectives:
Understand Notified Body Expectations: Participants will develop a clear understanding of the specific criteria and key aspects that notified bodies prioritize during their review of Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Clinical Development Plans (CDPs)
Enhance Efficiency in Documentation: Participants will learn practical strategies and tips to enhance efficiency when managing regulatory documentation.
Embrace Technology as a Strategic Investment: Participants will gain insights into viewing technology as a powerful tool for long-lasting compliance and ease of maintenance. They will learn to see technology adoption not just as a short-term solution, but as a strategic investment that pays off in sustainable regulatory compliance and streamlined maintenance processes.
