Online & Self-Paced Clinical Evaluation for Medical Devices Course

★★★★★

Overview

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.

This course 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.


Course Snapshot

  • Course Duration:

    8 Hours
  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner
    Comply Guru Certified Course
  • Delivery Options & Discounts

    • Discounts offered for 10+ Licenses
  • Price

    Not Yet Available
  • Fee Includes

    • Course Access for 90 days
    • Phone & Email Support
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Finally, an industry-leading online, blended & virtual training solution for compliance and certification!

Comply Guru™ offers a library of online, virtual & blended compliance training courses to enable its Learners to get the knowledge and skills they need, from the same systems and devices they use every day

Start DateLocationCostHoursActions
Anytime

Anywhere

  €8Hours
  • The following topics will be covered on this course:

    • Introduction to MEDDEV 2.7/1 rev 4
    • PMCF
    • Planning
    • Data analysis
    • Data appraisal
    • Data identification
    • Regulation intentions
    • Clinical investigations
    • Post-Market Surveillance

This course is fully certified by Comply Guru™.

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 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.

Some Companies that have used Comply Guru™

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The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 97%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 96%

    Would Recommend Online or Blended Training over Classroom Training

Custom Course Development

We can combine leading industry subject matter experts with an experienced eLearning team to help your organization with its compliance training needs.

Want to learn more? Get in touch.

Would you like to know more about our service? We have a dedicated sales team who would be happy to answer any questions that you may have.

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