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 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 [...]
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”
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
Drug Device Combination Products
4 – 5 December 2007 Brussels, Belgium
Drug Device Combination Products
Presentation on “Strategies for achieving the CE mark for combination products quickly and with minimal complexities”