June 04, 2018 - June 05, 2018
Training: 4 & 5 June 2018
Location: Universität Basel / Kollegienhaus in Basel, Switzerland
Price: €750,- for 1 day or €950,- for 2 days
Qserve has designed together with BSI 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.
More information: check the program flyer
Day 1 BSI - Hosted by Dr. Marco Rost
Organizational, Introduction etc.
Check device within the scope of the MDR / Determine risk class of device
Identify applicable safety and performance requirements
Apply conformity assessment procedure/ complete declaration of conformity/ Affic CE Mark
Post-market surveillance and updates
Transitional arrangements laid down in the Regulation
Day 2 Qserve - Hosted by Dr. Stefan Menzl
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 execution of audits
Electronic data management and public access to data
Labeling and UDI
Economic Operators (upstream, downstream)
Proposal how to implement a MDR project
Organizational, End of course, feedback, etc