Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU MDR 2017/745 requests particular attention to the management
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU MDR 2017/745 requests particular attention to the management
Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view; in this post I want to speak about the approach
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