Program Description

Medical Device Clinical Auditor Certificate

Estimated Learning Duration of the Program:
1-2 days
Program Description:

This program reviews the auditing regulatory environment that concerns all parties involved in medical device clinical investigations in the EU and US.

It covers the following topics:

  • What to expect from a BIMO inspection by the FDA
  • Basic principles of adverse event processes
  • Regulatory requirements in the EU and US for safety reporting during pre-market clinical investigations
  • Audits conducted as part of supplier qualifications

This program is designed for clinical auditors and is ideally combined with the Internal Auditor Certificate program to acquire a full understanding of the overall quality requirements of medical device companies.

Learning Objectives:

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

  • Understand the regulatory environments to be taken into account when auditing clinical investigations in the EU and US
  • Comprehend all auditing processes, including supplier qualifications

Price:€ 403.00

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