Sökning: "MDR CE"
Hittade 2 uppsatser innehållade orden MDR CE.
1. The Medical Device Regulation : What Impact Will the New Regulation Have on the Medical Device Industry and How Will Companies Use Standards to Meet the New Requirements
M1-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : The New Medical Device Regulations (MDR) will become affective on 26 May, 2021. The new regulation entails higher requirements for companies that develop medical devices, but also for all parties involved in the medical device industry. LÄS MER
2. The Impact of Medical Devices Regulations on Notified Bodies and Additive Manufacturing
Master-uppsats, Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknikSammanfattning : 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