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EU In Vitro Diagnostic Regulation (IVDR) 2019 – Seminar by BSI (Notified Body)

Oktober 22 @ 8:30 - 17:00 UTC+2

175€

22.10.2019

EU In Vitro Diagnostic Regulation (IVDR) 2019 – Seminar by BSI (Notified Body)

D-Berlin | BSI, Notified Body and BioLAGO partner invites to an 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. Experts and guest speakers are informing about some of the most significant changes to the European Regulatory and Compliance Expectations for CE marking. The event is exclusively focused on addressing the European IVDR. BSI will be sharing our current view on the new regulation and the expectations from the perspective of the leading global medical device Notified Body, ISO 13485 registrar, MDSAP Auditing Organization and world’s first national standards body.

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

*Session by Guest Speaker, Kalms Consulting GmbH

 

Dr. Heike Möhlig Zuttermeister will be the BSI speaker. She holds a PhD in Molecular Immunology. Prior to joining BSI in 2014, Heike worked for nine years as Head of Research and Development in life science and in-vitro diagnostic companies.

Programm
08:30am – 09:00am Networking Breakfast
09:00am – 09:15am Welcome and Introduction
09:15am – 10:00am IVDR Overview, Classification, Grouping Devices
10:00am – 10:45am Technical Documentation Requirements
10:45am – 11:15am Coffee Break
11:15am – 12:00pm New Requirements for Performance Evaluation
12:00pm – 13:00pm Lunch
13:00pm – 13:45pm Post-launch Requirements
13:45pm – 14:30pm Market Access and Reimbursement*
14:30pm – 15:15pm Workshop: Using the Remaining Transition Period Effectively
15:15pm – 15:45pm Coffee Break
15:45pm – 16:30pm Interacting with the Notified Body
16:30pm – 17:00pm Wrap up and questions

Kontakt

Food for future, BioLAGO Meeting Point, Lebensmittel von morgen, Uni meets Pharma, Wissenschaft-trifft-Wirtschaft, Science-meets-industry- Ansprechpartner

BSI Group Deutschland GmbH
Charlotte Hess
Sales Representative Medical Devices
Tel. +49 (0)69 2222 89 222
E-Mail: charlotte.hess@bsigroup.com

Termin

Datum:
22. Oktober 2019
Zeit:
08:30 – 17:00 Uhr
Kosten:
175,00 €

Veranstalter

BSI Group Deutschland GmbH
Website

Ort

Radisson Blu Hotel
Karl-Liebknecht-Str. 3
D-10178 Berlin
Google Maps & Routenplaner

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Bilder

Details

Datum:
Oktober 22
Zeit:
8:30 - 17:00
Eintritt:
175€

Veranstalter

BSI
Telefon:
+49 69 2222 8 9200
Website:
https://www.bsigroup.com/de-DE/

Veranstaltungsort

Radisson Blu Hotel
Karl-Liebknecht-Str. 3
Berlin, Berlin 10178 Deutschland
+ Google Karte
Telefon:
030 238280
Website:
radissonhotels.com