PSUR in EU MDR : Signal Detection Process & Challenges
Signal detection and risk management are new to medical devices. As PSUR reports for high-risk devices will be needing Signal Detection, manufacturers need to gear their processes Though the processes and methods are well established in Bio-Pharma, some of the areas that worked for those products may not work or applicable to Devices.
Topics covered in this Comprehensive Guide include:
- Signal Management Process
- Methods of Signal Detection
- Qualitative Method