Course Entry Criteria
Before completing this course, each Learner is recommended to have the following prior learning:
Risk Management- The fundamental concepts and principles of risk management as it applies to medical devices
- The commonly used risk terms and definitions (see ISO 14971)
ISO 13485:2016- A working knowledge of ISO 13485:2016, which may be gained by completing Comply Guru’s CQI & IRCA Certified ISO 13485:2016 Foundation Course
E-Learning System Requirements
The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or modules.
In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well.
Recommended Operating Systems
Windows 7/10, Mac OSX Sierra, iPad IOS10
Mobile Devices
Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.
Internet Speed
We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content
Recommended Internet Browsers
- Google Chrome 32 bit version 50 or later
- Safari 10 or later
Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge is
not recommended as its not compatible with the LMS and the course functionality will not work properly.
Recommended Settings
We recommend that the following settings are enabled:
- Cookies
- Pop-ups (in both Internet Browser and security software)
- JavaScript
- Plugins
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader
To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.
