| 1 x | GCP for Investigators: Initiation of a Medical Device Clinical Investigation | € 95.00 |
| 1 x | ISO 14155:2020 - Responsibilities of Principal Investigator | € 125.00 |
| 1 x | Understanding Clinical Evaluation for Notified Body and Regulatory Professionals | € 544.00 |
| 1 x | Medical Device GCP for Investigators | € 120.00 |
| 1 x | European Safety Reporting Requirements during Clinical Investigations | € 90.00 |
| 1 x | Managing Data Release Consent During Post Market Studies | € 75.00 |
| 1 x | GCP for Investigators: Introduction to Medical Devices | € 126.00 |
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
2 modules
€ 126.00
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