Date: 20th of August 2024
Time: 14:00 - 17:00 CET
Location: Virtual
Price: € 595,- | $ 643.-
Introduction:
Clinical evaluation can be a complex process, requiring a variety of skills not typically used in other regulatory documentation. In this course, we will guide you through a streamlined approach to clinical evaluation, simplifying data collection and analysis. We will explain how to establish endpoints for clinical claims, making the identification and assessment of relevant literature and other clinical data sources more straightforward.
The clinical evaluation course will effectively demonstrate how to establish endpoints, explore pitfalls in data collection for certain claims, and align data needs with the regulatory strategies required for compliance with MDR 2017/745 (WET, Equivalence, Article 61(10), etc.).
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.
Trainer: