Program Description

Clinical Evaluation for CE-Mark Certificate

Estimated Learning Duration of the Program:
1 day
Program Description:

This program is primarily designed to provide notified body auditors and regulators an in-depth review of clinical evaluation and investigation requirements in the EU and what to look for when inspecting the clinical section of a medical device manufacturer’s technical file.

The courses in this program provide a step-by-step review of existing clinical evaluation data, emphasizing how to correctly consider comparator devices and their data sets. They introduce a clear regulatory link between clinical evaluation reports of existing data and considerations for the need of prospective trials.

This program offers valuable tools for the essential review points of clinical investigation master files and safety reporting requirements. It has been peer-reviewed by the UK MHRA. Learners can further their knowledge of this program by completing the “ISO 14155: 2011 GCP ” certificate program.

Learning Objectives:

Upon successfully completing this program, learners will be able to:

  • Understand the essential elements and processes of medical device clinical evaluations for the CE-mark
  • Audit clinical files for sponsors
  • Detect non-compliances
  • Make valuable suggestions for improvement based on a full understanding of clinical evaluation
  • Support clinical colleagues with the essential clinical activities
  • Prepare for an NB audit

Program Pricing

Price1 onlyAs of 5As of 10As of 20As of 50
Price / person €235.00212.00188.00165.00Contact us
Price / person $277.30250.16221.84194.70Contact us