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This informative presentation outlines an initial assessment of the clinical evaluation aspects of the draft Regulation as a future substitute for the current Medical Device and Active Medical Device directives, made publically available on September 26th 2012.The main points covered are the changes in the clinical evaluation regulatory principles, followed by a gap analysis with ISO 14155 and a review of the clinical investigation process changes as proposed by the new regulation.



WMDO is proud to announce it's strategic partnership with EUCOMED and EDMA that offers their members access to WMDO's exclusive catalogue of professional online training. Under the agreement, EUCOMED and EDMA members will receive special benefits using the special login code provided on the EUCOMED website. 



Last September 27, 2012, WMDO held it's first CMDA exam for medical device clinical professionals in Switzerland and in the US. We want to congratulate our first graduates for their efforts and success in passing the exam. The next CMDA Clinical Evaluation exams will be held on April 5 and September 27, 2013 in Lausanne, Copenhagen, Singapore and Minneapolis (other locations upon request). Click here to know more about our Certification program.