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Assessing the Global Regulatory Landscape
- Autor: Vários
- Narrador: Vários
- Editor: Podcast
- Duración: 0:24:11
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Sinopsis
With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.Some of the highlights of this episode include:Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.EU MDR was supposed to go into effect in May 202