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 tagged europe
Regulation of standalone software as a medical deviceal
Medical Device Post Market Surveillance & Vigilance
16 – 18 February 2010, Berlin. Germany
Conference programme
Workshop on “Practical Issues in Developing a Strategy and Organisation for PMS” on 18 September
PMS, in particular its vigilance and clinical evaluation components, is
crucial in ensuring the survival of the manufacturer’s medical devices in
the increasingly regulated market place. This workshop will integrate
elements from the preceding conference days [...]
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 [...]
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 [...]
Course on Regulation of Combination Products and Other Technologies in the EU
11 December 2008 at University of Cranfield, UK
Course on Regulation of Combination Products and Other Technologies in the EU
Lecture on “Issues and specifics in clinical development of combination products”
Eucomed Regulatory Committee
13 – 14 October 2008,
Eucomed Regulatory Committee
Hilton Hotel Brussels, in Brussels, Belgium
Presentation on “The Revision of the New Approach”