Description

This is a basic online course about Clinical Evaluation through the lens of European regulatory systems, specifically the Medical Device Regulation (MDR).  The material supplies a quick overview of clinical evaluation from a realistic industrial perspective using recorded lectures and slides. The processes used in companies to conceive and develop clinical evaluation reports (CERs) will be explored from the standpoint of the MEDDEV 2.7/1 Rev 4 guidance document and its five stages of clinical evaluation. The course is 100% online and self-paced.    This course assumes no prior knowledge of clinical evaluation or EU Regulatory practices.  New students should be able to understand the entire content with  no prior background.

Clinical Evaluation Basics Course Objectives:

• Learn EU MDR requirements for Clinical Evaluation and Post-market Clinical Follow-up (PMCF)
• Define clinical evidence, clinical data, clinical evaluation
• Understand the relationship between clinical data, clinical evaluation, and clinical evidence
• Explain the five stages of clinical evaluation
• Explain how to create a Clinical Evaluation Plan (CEP) under MDR and MEDDEV 2.7/1 Rev 4
• Describe data collection processes and types

Who should take this course?

• Medical device project team members
• QA/RA Professionals with EU medical device projects
• Experienced professionals looking to brush up on EU MDR clinical evaluation

Clinical Evaluation Basics Course Outline:

• Introduction – Instructor greeting & course overview
• Introduction to the EU government and structure of the MDR
• Introduction to Clinical Evaluation
• Clinical Data and Clinical Evaluation
• The Clinical Evaluation Report (CER)
• Post-market Requirements
• Benefit-Risk Analysis

What you get:

• Unlimited time access to seven recorded online lectures (~ 1.5 hrs of content)
• Free updates to course material