Essentials of European Medical Device Regulatory Affairs 2018

Essentials of European Medical Device Regulatory

Affairs 21 June 2018

Programme

Time

Presentation

Presenter

09:00 Registration and Coffee 9.30 Welcome from TOPRA

Angela Stokes TOPRA President

9.35

Angela Stokes Global Regulatory Consulting, Syneos Health

Introductions

9.45

Angela Stokes

Module 1: What is a Device?

10:20

Neil Armstrong Global Regulatory Consulting, MeddiQuest

Module 2: Who is who

10.45 11:00

Coffee break

Angela Stokes

Module 3: Legislation

11:30

Angela Stokes

Module 4: Classification of devices

12:00 Lunch 12:45

Neil Armstrong

Module 5: Conformity Assessment

13:45

Neil Armstrong

Module 6: Device Labelling

14:15 Coffee break 14:30

Angela Stokes

Module 7: Clinical considerations

15:00

Neil Armstrong

Module 8: Post Marketing

16:00 Close of Meeting

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