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Found 2 essays matching the above criteria.

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

   University essay from Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknik

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

   Abstract : 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. READ MORE

3. 2. Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices

   University essay from Mälardalens högskola/Akademin för innovation, design och teknik

   Author : Aleksandër Pulla; Antonela Bregu; [2020]
   Keywords : AMASS project; certification; re-certification; efficiency; medical devices; ISO 14971; NBRG Consensus paper; reuse; standard; tool-chain; metrics; directives; regulations;

   Abstract : The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. READ MORE