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.
This audio conference covers:
- When a literature review alone is enough to provide clinical data for the technical file/design dossier
- The optimal way to perform a literature review and keep your notified body happy (avoiding issuance of non-conformities)
- Using the literature review as a tool for product development
- How the new MDD requirements place even more importance on clinical evaluations
- How clinical literature reviews can be used as a tool for risk management and post market surveillance
About the speaker:
Carol Houts is the Director of Regulatory, Quality and Safety Concerns for Pleiad, Inc., a full-service medical device CRO. She has more than 13 years of experience in quality, regulatory affairs, compliance, auditing, data management systems, vigilance, post-market surveillance, supplier management and regulatory compliance in both the medical device and pharmaceutical industries. Her regulatory expertise encompasses North America and European regulatory requirements, and she has supported both pilot and pivotal drug and device trials.
Who should attend?
- Regulatory specialists
- Regulatory managers
- Product development managers
- Clinical managers
- Medical writers
- Information scientists
*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.