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 [...]
27-29 January 2009 in Brussels, Belgium
Managing the Revisions to the Medical Device Directive
Chaired the conference.
Organised and led a workshop on “How to conduct Post Market Surveillance correctly”
Presentations on “Interface of the Medical Devices Directives with other
legislation in particular borderline issues” and “Basic legal and general aspects of Post-Market Surveillance”
Participated [...]
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
13 – 14 October 2008,
Eucomed Regulatory Committee
Hilton Hotel Brussels, in Brussels, Belgium
Presentation on “The Revision of the New Approach”