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Good Clinical Practice for Devices
Module Code C5.08
Course Overview
The advancement of science and technology is increasing the complexity of the medical devices. Now is the time to ensure the medical devices in your research are both safe and effective to use.
Our new GCP for Devices module will introduce you to the ISO 14155 International Standard and how it applies to your work, so you can ensure the devices you use are compliant with the latest regulations.
Strengthening your knowledge of ISO 14155 will ensure that your research is of a high standard and leads to excellent science, quality of data and reduced risk – all crucial for safe and effective medical devices.
This module has two pathways – for those who have not completed GCP training and for those who have.
This module also compliments our new GCP for Medical Devices virtual workshop, with the first workshop scheduled for 6 April 2022.
Participants can claim 3 CPD points on completion of this module.
How long will it take to complete?
This course takes on average 4-6 hours to complete.
Will I get a certificate of completion?
Yes! A certificate will be automatically issued once a minimum of 80% is achieved in the final quiz section of the module. You can download it immediately . The certificate will show evidence of this modules compliance with TransCelerate requirements.
When can I start?
You can begin at any time. This module is always open to enrolments as it is part of the Research Essentials training model.
What will you learn?
- Session 1 - What is / is not a medical device
- Session 2 - How regulations enable access to safe and effective medical devices
- Session 3 - Define GCP with reference to ISO 14155: 2020 and the laws and guidelines that govern the conduct of research
- Session 4 - How ISO standards 14971:2019 and 13485:2016 are relevant to ISO 14155:2020
- Session 5 - The essential documents required to begin a medical device clinical investigation
Note: Add Module Code C5.08 to the enrolment form where prompted
Price
$198pp plus GST
*Savings available for group enrolments and for PRAXIS partner organisations.
Suggestion box: new offers and interest areas
What would you like to see from us? This can be a topic we haven't covered yet, a course style, or a different way of delivering our courses and workshops. All suggestions are welcome and will be considered.