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
16 – 18 February 2010, Berlin. Germany
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 into a coherent and practical approach to PMS strategy and organisation.
Topics to be covered
• The place of PMS in the over-all compliance paradigm
• How the conference topics relate to this paradigm
• Organisational aspects of PMS in the global village
• Regulatory enforcement risk and how to minimise it through PMS
• How to optimise PMS to provide benefits beyond regulatory
compliance
• Future proofing of PMS
• Practical scenarios
What attendees will gain
Attendees will be able to reinforce what they have learned during the
conference lectures of the previous days by integrating them into a
coherent model. They will then gain insight into developing practical
strategies and organisational solutions for PMS using this model.
1 – 2 February 2010 Paris, France
Presentation on “Developing Effective Clinical Studies for Combination Products”
27 -29 January 2010, Brussels, Belgium
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”
17-19 November 2009 in Prague, Czech Republic
Drug Device Combination Products
Presentation on “Drug/device borderline – latest developments”
Organised and led a workshop on “Post Market Surveillance for Drug-Device Combination Products”
11 November 2009, Helsinki-Vantaa, Finland
New requirements for medical devices and software – what changes on 21.3.2009? (in Finnish)
Presentations on:
8 October 2009, Stockholm, Sweden
TOPRA Medical Devices Symposium
Presentation on “The Borderline and Classification Work Group – Industry Perspective”
23 – 24 September 2009, Galway, Ireland
Chairing the first day of the conference
Presentation on “Regulatory Framework for Combination Products in the EC “
7 – 9 September 2009, Cambridge, UK
Lecture and practical session on “Medical Device Classification”
25 – 26 March 2009, in Birmingham, UK
Presentations on “The Future of Medical Device Labelling in Europe” and “Conducting clinical trials under the revision”