FALLS CHURCH, Va. (PRWEB) March 24, 2020
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.
Expert Dan O’Leary, President of Ombu Enterprises, LLC, explains the EU MDR’s extensive requirements and concepts in his comprehensive, easy-to-understand approach:
- Understand the role of clinical trials in the EU MDR
- Learn which device types require clinical trials
- Determine whether an exemption applies to your device
- Learn how to integrate the EU MDR and ISO/DIS 14155:2018
- Understand the role of the Notified Body and Competent Authority
- Grasp the format and contents of the application, investigator’s brochure and clinical trials plan
- Determine informed consent requirements
Make sure one fully understands the EU MDR’s and ISO/DIS 14155:2018’s clinical trials requirements — how they work together and how to make them work.
Management Report Details:
Medical Device Trials in the EU:
A Guide to the New EU MDR and Revised ISO 14155
A CenterWatch Management Report
Management Report PDF:
Easy Ways to Order:
By phone: 888.838.5578 or 703.538.7600
Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.