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BSI 2019 EU In Vitro Diagnostic Regulation Roadshow

Date
Venue
Berlin
Costs
175 €
Address
Radisson Blu Hotel Berlin
Karl-Liebknecht-Str. 3
10178 Berlin
Germany
Directions
Type
information event
Organiser
BSI
Contact
phone: +49 (0)69 2222 89 222
e-mail: charlotte.hess(at)bsigroup.com
Language
English

The IVD industry is undergoing significant change – Are you prepared?

BSI is proud to announce the upcoming EU In Vitro Diagnostic Regulation (IVDR) Meeting in Berlin, a full day event for the IVD device manufacturer regulatory affairs, quality assurance and related consulting community. Join our experts and guest speakers to learn about some of the most significant changes to the European Regulatory and Compliance Expectations for CE marking.

Topics will include:

  • IVDR Overview, Classification, Grouping Devices
  • Technical Documentation Requirements
  • New Requirements for Performance Evaluation
  • Post-launch Requirements
  • Market Access and Reimbursement
  • Workshop: Using the Remaining Transition Period Effectively
  • Interacting with the Notified Body
Website address: https://www.gesundheitsindustrie-bw.de/en/event/2019-eu-vitro-diagnostic-regulation-roadshow