july, 2020

08jul9:00 am3:00 pmFrom IVDD to IVDR – smart transition (im-)possible?9:00 am - 3:00 pm Région:Deutschland

Specimen, medical devices medidee

Event Details

Organized by BIOPRO, join us to this gathering to talk about how to smartly prioritize the transition from IVDD to IVDR.
By organizing this meeting, Medidee wish to support the key European MedTech communities on their way to IVDR compliance by exposing the participants to a mix of strategic, tactical and hands-on materials. Ultimately, the participants should be further convinced that Medidee are the right partners for IVDR compliance.

Program preview
8:50 am Login & Digital Networking

09:20 Welcome Words BIOPRO Baden-Württemberg GmbH

09:30 Michael Maier, Medidee Services AG
“IVDR classification & lessons learned from the MDR transition”

10:00 Robyn Meurant, NSF Health Sciences Limited
“The extent of clinical evidence required for conformity assessment”

10:30 Dr. Sebastian Grömminger, Johner Institut GmbH
“Qualification and Classification of IVD-Software under IVDR”

11:00 Q&A Expert Session with Medidee Services AG, Johner Institut GmbH & NSF International

12:15 lunch break

1:00 p.m. PD Dr. Micha Nuebling, Paul Ehrlich Institute
“Expectations from the Paul Ehrlich Institute, vision on evaluation of class D IVD”

13:40 Dr. Silvia Anghel, Medidee Services AG
“Transition to IVDR: compliance, tactics and business cases”

14:10 Sabine Ohse, mdc medical device certification GmbH
“The View of a Notified Body: Maintenance of IVDD Certificates during the Transition Period”

2:50 pm Get together & Questions

Time

(Wednesday) 9:00 am - 3:00 pm

Location

Online Event

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