Open training: Clinical Investigation

January 16, 2019 / Europe

Date: 16 January 2019

Location: Amsterdam Area

Language: Presentations will be in English

Subscription for:  Regular  € 875.-

What will be the impact of the New Medical Device Regulation on Clinical Data Collection and Reporting for medical device manufacturers?     

To inform and prepare medical device manufacturers, Qserve has created a one-day training to explore the requirements of the new MDR on all aspects of clinical data collection and analysis. From setting up the protocol, collecting and reporting adequate clinical data to managing all parties involved including sites, IRB and CA.  

How will the EU MDR impact data collection in the post-market phase? What will be the status of clinical data collected under an Investigator-Initiated Study (IIS)? Does the manufacturer sufficiently control the site? Will there be an opportunity to monitor sites during an Investigator Initiated study? Can IIS clinical data be used to fulfill the Postmarket clinical follow-up requirements of a product? 

What clinical regulatory requirements will the EU MDR add on top of ISO 141555? A detailed comparison of the two will be discussed in this one-day training. 

The Qserve approach is to: 

Partner with you as the manufacturer, and work out a tailored clinical strategy; 
To familiarize ourselves with you, and your product and they understand the specific request for support; 
Outline the necessary steps towards clinical data collection, market approval and post-market clinical follow-up;  

This clinical investigation training can be provided as follows: 
1) as an open training to an audience of the different medical device manufacturer, or 
2) as a dedicated classroom training delivered to you on site.  

Who should attend:
Clinical, Development and Regulatory Professionals in Medical Device Industries

Gert W. Bos, PhD, Fraps
Anna Pietersma
Peter Reijntjes
Post date: October 11, 2018
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