Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, a clinical trial or a combination of the two.
This audio conference focuses on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation highlights pitfalls and best practices, and describe Medical Device Directive (MDD) requirements concerning clinical evaluations. This presentation also discusses use of the clinical literature review as a tool for post-market surveillance and as an input into risk management processes.
Taking the Literature Route for Clinical Evaluations was presented by Carol Houts, Director of Regulatory, Quality and Safety Concerns, with Pleiad and aired on 2008-07-24. This audio conference is available for download at www.fxconferences.com
