Online Clinical Evaluation 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.
This online course will offer a comprehensive overview of Clinical Evaluation for Medical Devices & MEDDEV 2.7/1.
In 2016, MEDDEV 2.7/1 rev 4 was published. This bought more stringent requirements for complying with clinical data evaluation. These requirements were not well understood by industry, and with the looming Medical Device Regulation, i has never been more imperative that you get clinical data right.
We have performed clinical data evaluation reviews for notified bodies and can offer you insights into common pitfalls. Plus you will get an understanding of what the requirements are really asking for.
We will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.
- 16 Hours
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The following topics will be covered on this course:
- Introduction to MEDDEV 2.7/1 rev 4
- Data analysis
- Data appraisal
- Data identification
- Regulation intentions
- Clinical investigations
- Post-Market Surveillance
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
- Quality Managers
- Regulatory Professionals
- Manufacturing Engineers
- Research and Design Engineers
- Quality Assurance 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