CenterWatch Announces -- Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155 Management Report
Retrieved on:
Martedì, Marzo 24, 2020
FALLS CHURCH, Va., March 24, 2020 /PRNewswire-PRWeb/ --The world of clinical trials is changing rapidly, with the EU MDR's new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates.
Key Points:
- FALLS CHURCH, Va., March 24, 2020 /PRNewswire-PRWeb/ --The world of clinical trials is changing rapidly, with the EU MDR's new and more complex rules and the forthcoming ISO/DIS 14155:2018 updates.
- The Medical Device Trials in the EU: A Guide to the New EU MDR and Revised ISO 14155 management report provides insight into the EU MDR's extensive requirements for documenting, conducting and reporting clinical trials, including which devices are exempt.
- Manufacturers of non-exempt devices must set up a clinical trials program using both EU MDR and ISO/DIS 14155:2018.
- Medical Device Trials in the EU: