Clinical Study Report Medical Devices

E3 Structure and Content of Clinical Study Reports | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-content-clinical-study-reports

The objective of this guideline is to facilitate the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory...

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For Questions about Medical Device Reporting, including interpretation of MDR policy: Call: …

Medical Device Clinical Trials: Regulatory …

https://www.greenlight.guru/blog/medical-device-clinical-trials

The processes for getting approval and initiating a clinical trial in the EU and US are different, so let’s take a look at each. Clinical trial regulatory …

What is a Clinical Evaluation Report (CER)? | Emergo by UL

https://www.emergobyul.com/resources/what-clinical-evaluation-report