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ABOUT THE COURSE
This is a professionally developed medical device training course which incorporates the Medical Devices Report (MDR) implemented in June 2017, along with ISO 14155 and in addition to regulatory guidance from the FDA and MHRA.
The Medical Devices Report (MDR), supersedes the previous Medical Devices Directive (MDD).
This course will enable you to:
- Become familiar with the regulatory requirements governing clinical trials involving Medical Devices.
- Understand the role of clinical studies in the development of medical devices.
- Develop in depth knowledge and understanding of the content and structure of the Medical Device Report and ISO 14155.
- Understand the responsibilities of each of the medical device stakeholders in light of ISO 14155 and consider practical implementation of these guidelines and regulations.
Finally an online learning platform thats fun, engaging and can be taken on any device, anywhere, anytime.
WlLL THE COURSE TAKE?
This course takes approx. 2-3 hrs to complete. This time will vary depending on the users previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.
At the end of the course the user can download and print their own certificate as a record of their course completion.
Chapter 1 - Defining Medical Devices
FDA and ISO definitions of a medical device
Examples of medical devices
Significant risk and non-significant risk devices.
Chapter 2 - Regulations & Guidelines Governing Medical Devices
How clinical research is regulated
Overview of ICH GCP
Medical device directives and Medical Devices Regulation 2017
ISO 14155:2011 and ISO 13485
ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
Chapter 3 - Device Development Processes
Medical Devices Classification:
- Class 1 (low to moderate risk)- General Controls
- Class II (moderate to high risk): Special Controls
- Class III (high risk): Pre- Market Approval (PMA)
Pre-market Notification (510 (k)), premarket approval (PMA) and CE marking.
Chapter 4 - Medical Device Regulations (MDR)
What is the MDR? What are the key changes?
MDR- Practical Implications for Sponsors
What is new with the MDR?
Chapter 5 - Medial Devices ISO 14155:2011
Intentions of ISO14155:2011
Informed consent processes
Investigator, sponsor and monitor responsibilities ISO 14155:2011
Chapter 6 - Clinical Investigation Plan ISO 14155:2011
Clinical Investigation Plan Structure and Content
Chapter 7 - Communicating with the Ethics Committee (EC) ISO 1415:2011
Chapter 8 - Investigational Device Exemption
IDE approval process
IDE exempt investigations
IDE approval timelines and application
Chapter 9 - Summary
Fiona Duthie, PhD
Ewelina Testoni, PhD
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