Online & Self-Paced ISO 13485:2016 Foundation Course (CQI & IRCA Application Made)

(5 Reviews, Click to view)


This fully online, self-paced course is ideal for anyone that wants to gain a comprehensive understanding of the requirements of ISO 13485:2016 and wants to flexibility to learn at their own pace and in their own time.

Request a free demo today to see if our training is for you!

Course Snapshot

  • Course Duration:

    8 Hours
  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner This course is certified by Comply Guru
  • Delivery Options & Discounts

    • Online & Self-Paced Only
    • Discounts Available for 10+ Licenses
  • Price

  • Fee Includes

    • Course Access for 90 days
    • Virtual Instructor Assistance – Phone & Email Support
A video about Comply Guru's online training library for compliance and certification

New! Online ISO 13485:2016 Foundation Course!

Eoin provides an overview on this new, exciting online course including what this self-paced course will cover and who will benefit most from completing it!

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

An application has been made to CQI & IRCA for certification of this course!

Start Date Location Cost Hours Actions Volume License


  • Module 0 - Course Introduction (Online & Self-Paced)

    In this module, an introduction to the course will be provided. This includes important information regarding the course content & learning objectives, duration, assessment methodology & how to successfully complete the course.

  • Module 1 - Introduction to ISO 13485:2016 (Online & Self-Paced)

    • Purpose, Benefits & Structure of ISO 13485:2016
    • Key Terms & Definitions
    • Principles of Quality Management
    • Relationship with ISO 9001
    • Key Revisions of ISO 13485
    • Key Concepts (PDCA, Process Approach, Risk Management)

  • Module 2 - Establishing a QMS (Online & Self-Paced)

    • QMS Processes
    • QMS Documentation
    • Document Control
    • Record Control

  • Module 3 - Management Responsibility (Online & Self-Paced)

    • Role of Top Management (Commitment, customer focus, quality policy, quality objectives, change control),
    • Responsibility
    • Authority and Communication
    • Management Review

  • Module 4 - Resource Management (Online & Self-Paced)

    • Resource Planning
    • Human Resources
    • Infrastructure
    • Work Environment and Contamination Control

  • Module 5 - Product Realization, Part 1 (Online & Self-Paced)

    • Planning of Product Realization & ISO 14971
    • Customer related Processes
    • Design & Development

  • Module 6 - Product Realization, Part 2 (Online & Self-Paced)

    • Purchasing
    • Production & Service Provision
    • Control of Monitoring & Measuring Equipment

  • Module 7 - Measurement, Analysis and Improvement (Online & Self-Paced)

    • Monitoring & Measurement (feedback, complaint handling, regulatory reporting & internal audit, process and product monitoring & measuring)
    • Control of Non-Conforming Product
    • Analysis of Data
    • Improvement (CAPA)

This course is fully certified by Comply Guru™. An application has been made to CQI & IRCA for course certification.

Successful completion will entitle each Learner to receive a certificate of completion.

  • The wording was very different to the standard. I found it hard to try and match things up because they were worded differently. Not a bad thing but I found it a little time consuming matching wording.

    Sarah Jane O'Farrell | August 11, 2020

  • As a former Quality Manager with direct reports in regulatory quality assurance and quality control I can highly recommend this excellent course. The blend of supporting on line documentation plus well thought out and delivered video clips ensures that the content is of the required standard duration and is delivered in an authoritative and informative style. The additional technical information supplied in the resource section augments the course content and provides that extra detail gat makes all the difference.

    Brian O'Connell | August 11, 2020

  • Experience is good, and your support off line is excellent in terms of helping to resolve tech issues

    Alicia Baldonedo | August 6, 2020

  • I really enjoyed this training and found it beneficial particularly before internal auditor training. The mix of videos, scenarios and assessments were really engaging even though the training was delivered online.

    Jade Dalton | August 6, 2020

  • An excellent, well written course! I had very little knowledge on ISO 13485:2016 and this has now given me an excellent understanding of the standard. Being able to do the modules at your own pace, in your own time is perfect. Thanks again!

    Abbie Ambridge | August 5, 2020

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.

What each Learner should know before completing this course:

CQI & IRCA recommend only  that each Learner have the following prior knowledge before completing this course which would be beneficial, but it is not required in order to register for this course: Management systems 
  • The Plan, Do, Check, Act (PDCA) cycle
  • The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
Quality Management
  • The fundamental concepts and commonly used quality management terms and definitions

Printed Copy of ISO 13485:2016

  • Each participant should have a printed copy of the standard to reference while completing this course. This is not provided by Comply Guru and without it, this course will be very challenging to complete successfully.

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 are 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™

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

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.

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