ISO 14155: 2011 – A Summary Review
For all medical device professionals on the go who are short on formal knowledge concerning the latest revision of the ISO 14155, but who do not require the comprehensive or in-depth details as found in the certification program: ISO 14155: In Depth Review, WMDO proposes this condensed yet inclusive summary review of the standard to get them up to speed.
ISO 14155: 2011 A Summary Review will provide you with an understanding on when to apply the ISO 14155 requirements, what are the basics of the ethics requirements, a list of essential tasks and elements during preparation, conduct and closing a clinical investigation with a brief explanation of the main responsibilities of the sponsor and investigator.
Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend the general requirements of the ISO 14155 as a GCP guidance specifically for medical device clinical investigations
- Comprehend ISO 14155 requirements for ethics committee or IRB process requirements throughout the world.
- Comprehend and identify the requirements of the informed consent process
- Comprehend the activities before planning a clinical investigation, during a clinical investigation and at termination of a clinical investigation
- Comprehend in general the responsibilities of the sponsor and investigator.
All clinical professionals, quality assurance professionals involved with clinical data as well as regulatory professionals involved with clinical investigations for medical devices.
There are no current requirements or pre-requisites concerning this course.