How to survive the Perfect Storm – International Harmonization and Lessons from Brexit and the MDR Apr 24, 2019

This month we look at global regulatory strategy in times of uncertainty. Remember just yesterday when CE was a smooth and quick process and CE mark gave a passport to so many other markets. Suddenly everything changed. We look at what the implications of changes in Europe (MDR Brexit), the US (New 5410k pathways, SaMD) and other markets such as Australia (leveraging Canada, Japan as well as US and CE) and of course, MDSAP. And amongst all of this we have to keep in sight the commercial and marketing objectives. Join Arthur Brandwood and Grant Bennett who ask: “how do I build a global regulatory strategy that is fit for today, and for whatever tomorrow may bring?”
Presented by: Arthur Brandwood and Grant Bennett, Brandwood Biomedical

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