General Information
| Topic of the Course | Clinical Evaluation Process |
| Course Duration | 3,5- 4 hours |
| Type of Course | e-Learning, Online & Self-Paced |
| Course Material Available | No |
| Transcript Available | No |
Course Contents
Section 0 – General Introduction to the Course
Course Description and Duration
Structure of the Course
Objective of the Course
Assessment of Learning AchievementsPrerequisite and
Course Certificate
Section 1- Introduction to Clinical Evaluation
Clinical Evaluation Requirements
Guidelines for Clinical Evaluation
Terms & DefinitionsSection 2a – Application of the Clinical Evaluation Process
Regulatory Requirements for Clinical Evaluation
Clinical Evaluation Plan Clinical Evaluation Plan for Legacy Devices The concept of State of the ArtSection 2b – Application of the Clinical Evaluation Process
Identification of Available Clinical Data
Appraisal of Clinical Data Analysis of Clinical Data Clinical Evaluation ReportSection 3 – Clinical Investigation & Related Requirements
Clinical Investigation Investigation Brochure Safety reporting for clinical investigation Clinical Investigation ReportSection 4 – Clinical Evaluation and Post-Market Surveillance
Clinical Evaluation & Post-Market Surveillance Post-Market Clinical Follow-up Process PMCF Plan: Overview of the main ContentsGeneral Information
General Description
This online & Self-Paced Training Course is focused on the Clinical Evaluation Process, according to the requirements of EU MDR 2017/745 . For a more detailed description of the course, refer to the section related to the course contents.
Who Should Attend the course?
This course should be followed by anyone interested in clinical evaluation for medical device sector, including clinical investigation, post-market clinical studies, strategy for determining equivalence and related topics.
Course Access
You need to register before to have access to the course. Registration can be performed at this link; once the registration is successful, you will redirect automatically to the page listing all the courses.
Structure of the Course
This course is divided into five different sections. At the end of each session, there are some tests and exercises aimed at consolidating the information related to each part of the course. At the very end of the course, a final test shall be performed.
Course Certificate
At the end of the course, upon successful completion of all the intermediary and test. Each test shall be passed with a minimum score of 70%.
Prerequisites
No specific prerequisites are requested to attend this course. However, general knowledge of ISO 13485 and EU MDR / IVDR would be beneficial, although not mandatory or requested.
