Post-Market Literature Surveillance: Systematic Literature Review and Case Study Webinar
Joining Criterion Edge’s President Laurie Mitchell, is our guest speaker, Queenita Fernandes, Medtronic’s Medical Safety Manager, Patient Monitoring & Respiratory Interventions. In this webinar, we will discuss how to deploy systematic literature review in order to augment post-market clinical surveillance, and share our best tips on a robust systematic literature review process. Following this, our guest speaker will share an informative case study illustrating more.
Who should watch this webinar?
Those Regulatory, Quality and Clinical leaders and regulatory writers who are tasked with the development, writing, review or approval of Clinical Evaluation Reports for EU MDR submission, or anyone interested in learning more about MDR requirements for CERs.
Click here to watch the webinar recording.
How Can a Systematic Literature Review (SLR) Help Prevent Common Pitfalls in Meeting the Elementary Requirements of Clinical Evaluation for MEDDEV 2.7/1 revision 4 Clinical Evaluation Report (CER)?
Performing a methodologically sound literature review in the early stages of product development, as well as in the later stages, can help reduce most of the inadequacies highlighted by the European Commission in section A6 of MEDDEV 2.7/1 revision 4. Section A6 provides examples of studies that lack scientific validity for the demonstration of adequate clinical performance and/or safety.
Here are the seven areas highlighted in section A6 of MEDDEV 2.7/1 revision 4 that manufacturers tend to have the most problems in proving scientific validity:
- Lack of information on elementary aspects
- Numbers too small for statistical significance
- Improper statistical methods
- Lack of adequate controls
- Improper collection of mortality and serious adverse events data
- Misinterpretation by the authors
- Illegal activities
Read more about the implications of these problems and how to improve in our blog post, here.