Online Application of Risk Management and ISO 14971 to Medical Devices Course

★★★★★

Overview

Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this course!

Meddev Solutions Logo-Large

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 an interactive overview of the application of risk management to medical devices. It provides an overview to ensure you understand the requirements of the harmonised standard EN ISO 14971.

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.

  • 2 Hours
Online Application of Risk Management and ISO 14971 to Medical Devices Course

The Numbers - How We Are Doing

  • 100%

    Our Pass Rate

  • 100%

    Would Recommend Comply Guru

  • 99%

    Gave us 4/5 Stars or higher Overall Training Experience

  • 95%

    Would Recommend Online or Blended Training over Classroom Training

Some Companies that have used Comply Guru™

Start Date Location Cost Hours Actions
Anytime

Anywhere

  € 2Hours
  • The following topics will be covered on this course:

    • Introduction to EN ISO 14971
    • 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)

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 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.

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.

*Fields (all mandatory)