Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of 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, clinical trials, or a combination of the two.

This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MedDEV 2.7.1/3, which was issued in 2009.

This audio conference covers:

• The new MedDEV 2.7.1/3 guidance and how to comply
• The optimal way to prepare a clinical evaluation report and keep your notified body happy (avoiding issuance of non-conformities)
• Things to include in your SOP on clinical evaluation reports and template clinical evaluation report

About the speaker:

Helen Colquhoun is CEO of Pleiad Inc, a full-service medical device CRO. She has worked in the medical device and pharmaceutical industries for more than 20 years. She is a physician with a depth of experience in vigilance, pharmacovigilance, regulatory affairs, clinical study design and management, and product development planning. Her expertise covers North America and Europe. She is based in Cambridge, Massachusetts.

Who should attend?

• Regulatory Specialists
• Quality Specialists
• Medical Writers
• Information Scientists