Mika Reinikainen is chairing a full day session on “Software Regulation and Validation” and speaking about “Software as a Medical Device: European Legal and Regulatory Basis” on 25 March
at the Medtec Europe Conference
23–25 March 2010, Landesmesse Stuttgart, Stuttgart, Germany
Software as a Medical Device: European Legal and
Regulatory Basis
Archive of posts filed under the Presentations category.
Regulation of standalone software as a medical deviceal
BIOMEDEVICE
1 – 2 February 2010 Paris, France
BIOMEDEVICE
Presentation on “Developing Effective Clinical Studies for Combination Products”
The Medical Device Directive
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”
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 [...]
TOPRA Medical Devices Symposium
8 October 2009, Stockholm, Sweden
TOPRA Medical Devices Symposium
Presentation on “The Borderline and Classification Work Group – Industry Perspective”
Medtec Ireland
23 – 24 September 2009, Galway, Ireland
Medtec Ireland
Chairing the first day of the conference
Presentation on “Regulatory Framework for Combination Products in the EC “
Birmingham 2009
25 – 26 March 2009, in Birmingham, UK
Presentations on “The Future of Medical Device Labelling in Europe” and “Conducting clinical trials under the revision”
MEDTEC Europe 2009
March 3-5, 2009 Stuttgart, Germany
MEDTEC Europe
Chaired Session on “Regulation”.
Presentation on “The Future of Medical Regulations in Europe”
Managing the Revisions to the Medical Device Directive
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 [...]
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