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1. 1. The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing

   Master-uppsats, Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknik

   Författare :Jianing Qi; Shilun Wei; [2020]
   Nyckelord :Medical device regulation; Notified Bodies; Additive Manufacturing; Additive Manufacturing in healthcare;

   Sammanfattning : The medical device regulatory system, as well as the medical device market in the European Union (EU), is now facing challenges posed by the newest regulation, Medical device regulations (MDR). Researches have shown concerns and possible consequences related to this new regulation system from both the regulatory approval procedure and market development perspectives. LÄS MER