Course Description

Data from Prospective Clinical Investigation for CE-Mark: Review for Regulatory Professionals

Course Description:

The course provides detailed insight into clinical investigation reviews for both the CE-Mark and post-market surveillance program. It particularly focuses on the aspects of clinical investigation reviews that notified bodies and regulatory authority reviewers pay attention to during the reviewing process.

This course complies with the requirements of the EU Medical Device Regulations, MEDDEV 2.7.1, MEDDEV 2.7.1, ISO 14155 as well as the NBOG checklist for auditing clinical investigations.

Learning Objectives:

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

  • Understand the objectives of clinical investigations
  • Draw meaningful conclusions from the results of clinical investigations
  • Comply with the requirements of EU-MDR MEDDEV 2.7.1, ISO 14155  and the NBOG checklist
  • Prepare for notified body audits by recognizing notified bodies’ specific focus points

Who Should Enroll:

Regulatory affairs managers, quality assurance managers and engineers, notified body and regulatory authority clinical reviewers, lead auditors, R&D engineers, and marketing managers are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

The following material is required:

  • MEDDEV 2.7.1
  • EU-MDR – clinical requirements – are also covered in this course.
  • Related NBOG documents

Subject Matter Expert:

95 min

Related resources:

Case studies:

Basic Account: € 418.00
Premium Account: € 314.00

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