Training on the Fundamentals of the MDR in Germany

June 27, 2018 / Europe

Training: 27 & 28 June 2018

Location: Frankfurt, Germany

Language: English / German

Price:  Regular € 750.-
            Early Bird: € 675.- (until 26 May 2018)

Qserve has designed a 2-day high profile workshop program to assist in determining the crucial steps needed for your organization. 

Did you know that the EU MDR is effective since the 25th of May and needs to be implemented by spring 2020, which means that the Medical Device sector needs to increase its compliance level? GAP assessment, Portfolio Analysis, Global Impact Assessment are just some of the steps on the road to EU MDR implementation that must be addressed to ensure compliance.

 

 Learning Objectives:

On completion of the training, participants will be able to:
• Understand the Medical Device Regulations approach in Europe
• Understand the structure and purpose of Medical Device Regulation
• Explain the use of Essential principles including the use of (harmonized) standards and Common
Specifications
• Apply the new Classification Criteria and Implementation rules
• Identify the new conformity assessment routes
• Identify revised Technical Documentation requirements
• Importance and role of Clinical Data
• Identify the importance and contents of Post Market Surveillance

Program Overview:

• Medical Device Regulation and the New Approach
• Legal and operational structure
• Structure and purpose of MDR EU 2017/745
• General Contents of MDR EU 2017/745
• New conformity assessment routes
• Essential Principles
• Role and importance of Risk Management
• Active Post Market Surveillance & PMCF
• Revisions to Vigilance and reporting to the Competent Authority
• Clinical Evaluation & Clinical Investigation
• Questions & Answers
• Evaluation of the Course and Closing

 

 

Speaker:

Stefan Menzl
Post date: June 27, 2018
Tags
Subscribe to the Qserve Newsletter and follow us on LinkedIn
Want more information? Please contact us.
Information request