GCP for Investigators: Introduction to Medical Devices
GCP for Investigators: Introduction to Medical Devices
This course provides basic and background information on medical device Good Clinical Practice (GCP).
It covers the following topics:
- Overview of essential elements
- Review of the regulatory environment of medical devices in the EU and US
- How the Declaration of Helsinki applies to the medical device field
- Relevant GCP regulatory documents
- Major differences between ICH E6 GCP and medical device GCP as outlined in ISO 14155
- Necessary manufacturing steps for conducting clinical investigations
- Brief review of the elements of medical device study designs
The content of this course is based on:
- ISO 14155: 2011: Clinical Investigation of Medical Devices for Human Subjects
- The Declaration of Helsinki
- 21 CRF 812: Investigational Device Exemption
- 21 CRF 50: Protection of Human Subjects
ID: 193
52 minutes
2 modules
€ 126.00
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Learning Objectives
Upon successfully completing this course, learners will be able to:
- Acquire a working knowledge of the applicable GCP regulatory documents for medical devices
- Comprehend and define the medical device regulatory environment from an objective perspective
- Interpret the different essential documents for medical device clinical investigations
- Contribute to compliance throughout medical device clinical investigation processes
Who Should Enroll
Principal and co-investigators, study coordinators, site managers, and hospital or ancillary staff involved in the clinical aspects of medical device clinical investigations are all encouraged to enroll in this course.
Prerequisite Knowledge
The following course is required:
- History of Good Clinical Practice (GCP) (41)