Live Training | Clinical Investigation Design and Clinical Investigation Requirements under the European Medical Device Regulation to achieve MDR certification

Date: 16 January 2025

Location: Shanghai, China

Time: 09:00–17:00 CST

Price: 1250 CNY / € 162,- 

Language: English

Introduction

The training will focus on how to conduct clinical investigations in Europe under the MDR and how it relates to a clinical evaluation to be used for submission to the Notified Body. In addition, we will focus on the process and interaction with the Notified Body and share experience on how to ensure an efficient process toward MDR CE certification, especially for high-risk devices with class III and IIb implants.

Qserve is the largest CRO and consulting organization for medical devices and IVD's in Europe and combines aCRO for clinical investigations with a high level of regulatory and clinical consultancy to help its customers successfully achieve CE certification in Europe, specializing in high-risk devices. Qserve's senior staff includes people who have spent a large part of their career in senior positions at the key Notified Bodies TÜV, BSI, DEKRA, and SGS.

Program

1. Regulatory environment of Clinical Investigation in Europe. Which regulations, standards, guidelines regulate clinical studies in Europe? 
2. Clinical strategy under the MDR. What are the connections between clinical evaluation and clinical investigation? When and how to set up a Clinical Strategy Plan (consideration for the expert panel consultation)?
3. From clinical evaluation to Clinical Investigation Plan. How is clinical evaluation supporting the proper design of clinical investigation under MDR? How to set up my study objectives and endpoints? Clinical development stage and statistical consideration.
4. Clinical Investigation review process under MDR. Which documents must be submitted as part of my study application? How long does the review process take in the EU? What are the frequently asked questions?
5. Clinical Investigation requirements under MDR. What are the reporting requirements during the study and at the study end? 
6. Clinical investigation documentation during  conformity assessment. Which clinical documentation is required by notified bodies? How to utilize and present non-European clinical trial data to get CE marking? How to interact effectively with NB
7. Overall Summary. Take home message and Do's and Don’ts.

The training will be co-hosted by Jenscare professionals.

Who should attend?

• Clinical Affairs / Regulatory Affairs 
• Manufacturers of high-risks devices
  

Qserve Trainers