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 Medical device
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 [...]
TOPRA Medical Devices Symposium
8 October 2009, Stockholm, Sweden
TOPRA Medical Devices Symposium
Presentation on “The Borderline and Classification Work Group – Industry Perspective”
Medical Device Summer School
7 – 9 September 2009, Cambridge, UK
Medical Device Summer School
Lecture and practical session on “Medical Device Classification”
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”
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
Medical Device Law and Compliance Forum
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