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 Directive
Regulation of standalone software as a medical deviceal
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 [...]
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”