27 -29 January 2010, Brussels, Belgium
Understanding the Impacts of Horizontal
Legislations on Medical Devices
The Medical Device Directive programme
Presentation on “Update on classification”
Chaired a workshop on “Understanding the Impacts of Horizontal Legislations on Medical Devices” and gave a presentation on “Revision of the New Approach”
Archive of posts tagged legal
The Medical Device Directive
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
Medtech Europe 2008
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”
Current State and Future Evolution of European Regulatory Requirements
13-14 February 2008, in Birmingham, UK
Presentation on “Current State and Future Evolution of European Regulatory Requirements”