Virtual Training | Clinical Evaluation

Date:  19th of June 2024 

Time: 14:00 - 17:00 CET   

Introduction:

Clinical evaluation can be a daunting process as it involves many different skillsets that are not often used for other regulatory documentation.  In this 5-hour series, broken down into two sessions, we will walk you through a clinical evaluation approach that can simplify data collection and analysis.  These virtual training sessions explain how to establish endpoints for clinical claims that will make identifying and assessing relevant literature and other clinical data sources more straight-forward.

The series starts with a virtual training on clinical evaluation that will demonstrate an effective means to establish endpoints, explore pitfalls of certain claims in terms of data collection, and align data needs with regulatory strategies required for compliance to the MDR 2017/745 (WET, Equivalence, Article 61(10), etc.).  This session will last 3 hours.

The clinical evaluation course will provide guidance on how to properly use literature search engine fields to get the best results and how to define search terms that enable identification of data relevant to the device under evaluation and establishing state-of-the-art.