Preparing for MDR/IVDR | Clinical data considerations

« Medidee Services, the leading medical and in-vitro diagnostics devices consultancy firm is delighted to invite you for a discussion around clinical data considerations. This event is a unique opportunity to meet and share clinical/performance evaluation knowledge and experience  with our experts in order to set-up or reinforce your clinical strategy under the MDR/IVDR. »

Meet & share with experts about clinical/performance evaluation and get ready for your MDR/IVDR clinical strategy.

AGENDA:

09:30     Welcome and Opening

10:00     Introduction talk Introduction on Karl Stortz Visitor Center

              Silke Bendias | Director Visitor & Training Center Berlin

10:15     Clinical data expectations from a notified body

              Anthony Wilkinson | TÜV SÜD Clinical Manager

11:00     Tips to write efficient CER and Performance evaluations

              Dr. Sandra Klompmaker | Medidee Services

11:45     Panel discussion

              Chair: Raimo Sump | Medidee Services

12:00     Lunch & Meet break – food included

13:30     How to do efficient clinical data management / E-CRF

              Yossi Tal, PhD. | President, TechnoSTAT

14:15     Statistics for medical devices

              Tim Farley, PhD. | Medidee Services

15:00     Coffee Break

15:30     Lessons learned on MDR/IVDR processes

              Michael Maier | Medidee Services

16:00     Panel discussion

              Chair: Raimo Sump | Medidee Services

16:30     Networking

Entry fee: EUR 250 (excl. VAT) biosaxony members and partners get a discount of 15% (please ask for the code at marketing@biosaxony.com)

Registration deadline: 10.10.2019

Registration details: training@medidee.com / +49 170 96 01 473

Location:

KARL STORZ SE & Co. KG

Besucher- und Schulugszentrum Berlin

Scharnhorstrasse 3

10115 Berlin