Open Training Clinical Affairs: "Efficient Clinical Evaluation for medical devices"

May 24, 2018 / Europe

Training: 24 May 2018

Location: Amsterdam, the Netherlands

Language: English

Subscription:   On request  (info@qservegroup.com)


Who should attend?


As a regulatory or clinical resource or design- and development engineer we do not need to tell you about the increasing regulatory requirements for medical devices in Europe. Also, changes in Notified Body expectations are nothing new to you as a medical device manufacturer. But do you ever worry about clinical evaluation reports eating away your clinical and regulatory budget? Or how to integrate the requirements for postmarket clinical-follow up in an effective and efficient way?  

Then a practical training is good news to you! 

Who are we?
Qserve is dedicated to support medical device manufacturers with their Clinical Evaluation during all phases of the medical device product lifecycle. Since each medical device has a unique place in the market we are dedicated to an efficient approach of clinical evaluation. 

Topics covered:
In this one-day training, you will learn to design a clinical evaluation strategy specific to the desired claims and risks, in compliance with regulatory requirements.

Clinical data collection for medical devices, first time right:

Designing the right strategies throughout the product lifecycle to collect required data.
Reviewing literature to retrieve available data.
Develop the right question for clinical investigation.
Completing and maintaining the clinical evaluation report.

 

 

Trainers:

Loes Pelgrim
Anna Pietersma
Wiebe Postma
Post date: March 20, 2018
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