The Medical devices market was revolutionized by the European Union’s new rules for submissions in 2010. The Clinical Evaluation Plan/Reports have been a challenge for companies to get a handle on for submissions. This is a great opportunity for information professionals to be a part of the process to make the submission successful. In this presentation, an overview of the regulations and approaches to compliance from literature searching to document review and reporting will be discussed in a panel that will include experts from three different organizations.
Program Takeaways
- Participants will understand Clinical Evaluation Report (CER) requirements and also the geographies where CERs are required
- Participants will become familiar with how to search the literature to support CER preparation
Session Presentation - Crumlish
Session Presentation - Hana Vegher
