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 [...]
8 October 2009, Stockholm, Sweden
TOPRA Medical Devices Symposium
Presentation on “The Borderline and Classification Work Group – Industry Perspective”
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
September 23 – 24, 2008 in Brussels, Belgium
Medical Device Law and Compliance Forum
Presentation on “Borderline issues: The demarcation of medical devices from other products: medicinal products, ATMPs, machinery, PPEs, food supplements and cosmetics”
Conference website
11 March 2008, in Stuttgart, Germany
Medtec Europe
Chaired Session on “Changing Requirements in Europe (Directive 2007/47/EC and New MEDDEV on Vigilance)”
Presentation on “Changes in Classification and Legal Regime Borderline”