Essays about: "Notified Bodies"
Found 2 essays containing the words Notified Bodies.
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1. The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing
University essay from Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknikAbstract : 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
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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 teknikAbstract : 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