Online Regulation Basics for Medical Devices Course
Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this course!
Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.
We are delighted to offer an online interactive overview of the application of various regulations that apply to medical devices and the various country jurisdictions they are sold into.
Regulatory compliance is key to being able to sell devices into various countries. This course provides a basic overview of a countries requirements from classifying the device, registration through to post-market requirements.
It will give you the resources you need to understand what will be required when entering a new market. It also provides an opportunity for internal auditors to ensure requirements are being met within your product portfolio.
The courses are written per country and covers medical devices of all classes.
- 2 Hours
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The following topics will be covered on this course:
- Introduction to the regulation
- Device classification
- Device registration
- Labelling requirements
- Establishment registration
- Vigilance and recalls
- Where to find out more
This course is fully certified by Comply Guru™ & Meddev Solutions.
In order to successfully complete the course, each Learner will need to obtain a grade of 70% or higher in the final examination. Successful completion will entitle each Learner to receive a certificate of completion.
This course would be targeted at:
- Quality Engineers
- Research and Design Engineers
- Internal Auditors
- Quality Managers
- Regulatory Professionals
In order to successfully complete this online course, each Learner will need to:
- Complete the online course modules and obtain 70% or higher in the final assessment (MCQ-based Assessment)
E-Learning System RequirementsThe 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 SystemsWindows 7/10, Mac OSX Sierra, iPad IOS10
Mobile DevicesComply 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 SpeedWe 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
Recommended SettingsWe recommend that the following settings are enabled:
- Pop-ups (in both Internet Browser and security software)
- Latest Version of Adobe Flash Player
- Latest Version of Adobe Acrobat Reader