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Online & Self-Paced Risk Management & ISO 14971:2019 [including Key Changes] Course

★★★★★

Overview

This online course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019 which has just been released & includes an overview of the key changes.

The current law, medical devices directive 93/42/EC requires implementation of the state of the art, implementation of the harmonised standard provides presumption of conformity. The future regulation builds on the requirements of risk management.

EN ISO 13485:2016 requires medical device manufactures to implement a Quality Management System that has a greater emphasis on risk. This course for medical device manufactures has been developed to meet this more rigorous focus on risk management

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 are 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 Guruâ„¢ 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

How to Purchase Course Content Certification Who Should Attend How Will I Be Assessed Technology Requirements

This course is online, self-paced & available 24/7/365

Learn Anytime, Anywhere - Coming September 2020!

Start DateLocationCostHoursActions
Anytime

Anywhere

   €8Hours

  • The following topics will be covered on this course:

    • Comprehensive Overview of EN ISO 14971:2019
    • The key changes from 2012 > 2019
    • The procedure and plan
    • Risk Assessment tools
    • Application to ISO 13485
    • Relationship with other standards: the 60601/61010 series; Usability (EN 62366); Biocompatibility (ISO 10993)

    ++MORE INFORMATION COMING SOON!

This course is fully certified by Comply Guruâ„¢

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 Assurance Professionals
  • Quality Engineers
  • Research and Design Engineers
  • Internal Auditors
  • Quality Managers
  • Manufacturing Engineers
  • 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 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.

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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

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