Archive of posts tagged drug device

Drug Device Combination Products

17-19 November 2009 in Prague, Czech Republic
Drug Device Combination Products
Presentation on “Drug/device borderline – latest developments”
Organised and led a workshop on “Post Market Surveillance for Drug-Device Combination Products”

New requirements for medical devices and software – what changes on 21.3.2009?

11 November 2009, Helsinki-Vantaa, Finland
New requirements for medical devices and software – what changes on 21.3.2009? (in Finnish)
Presentations on:

Direktiivin 2007/47/EY (medical devices) sisältö ja merkitys alan eri toimijoille (The contents and significance of Directive 2007/47/EC to different stakeholders in the field)
Laiteluokittelu, raja-alueet, tulkintaohjeet, MEDDEV-oppaat – mitä uutta on tulossa (Device classification, borderlines, guidance, MEDDEV documents [...]

Drug Device Combination Products

27 – 29 October 2008, in Barcelona, Spain

Drug Device Combination Products

Organised and led a workshop on “Developing effective clinical studies for combination products”
Presentation on “Combination products: legal considerations in borderline determination and clinical implications” and “How have the revisions to the Medical Device Directive impacted on combination product approval?”
Event website

Drug Device Combination Products

4 – 5 December 2007 Brussels, Belgium

Drug Device Combination Products
Presentation on “Strategies for achieving the CE mark for combination products quickly and with minimal complexities”