Clinical Suite | Clinical Evaluation under the MDR

Clinical Suite | Clinical Evaluation under the MDR

Date: 9 March 2023 
Time: 18:00 – 21:00 CET | 12-3 pm EST
Location: Virtual
Language: English
Price in Euro: € 595,-

Packages
Price in Euro: € 1495,-* for all 5 sessions

* Team Members with Different Roles & Responsibilities? No problem! We offer flexible options for your company, team, or individual experts. You can send different delegates from your company to the sessions and still qualify for the package.

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 final 2 hour session in the 2-part clinical evaluation series 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

Jasmin Hunter

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