Visit our modular, 2-day workshop for the MDD to MDR transition on 04th – 05th of June 2018 at the Kollegienhaus of the University of Basel.
This workshop will take place in collaboration with Qserve.
Our tutors and international experts Dr. Marco Rost (BSI Group) and Stefan Menzl, PhD (Qserve) will give you a broad overview of the new MDR.
Date: 04 th - 05 th of June 2018
Location: Universität Basel, Kollegienhaus, Petersplatz 1, CH-4051 Basel
Time: 09 am to 05 pm
Pricing per 1 Day: 750 €
Pricing per 2 Days: 950 €
Agenda - Day 1 - BSI Training Academy
• Organizational, Introduction
• Check device is with the scope of the MDR/ Determine risk class of device
• Identify applicable safety and perfomance requirements
• Apply conformity assessment procedure / Complete declaration of conformity / Affix CE mark
• Post-market surveillance and updates
• Transitional arrangements laid down in the Regulation
Agenda - Day 2 - Qserve
• Changes to the structure and administration of the regulation
• Important changes to the requirements for conformity assessment
• Main effects on the QMS in connection with the o.G. Steps, including:
• Frequency, scope and execution
• Electronic data management and
public access to data
• Clinical Data with Case Study
• Labelling and UDI
• Economic Operators - Upstream and Downstream
• Proposal how to implement a MDR project
• Organizational, End of course, feedback
Do you have any questions? Please contact Oliver.Schaer@bsigroup.com or call us +49 69 2222 89 265
Please filling in the form below to register for the workshop!