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

(36 Reviews, Click to view)


This CQI & IRCA Certified Online & Self-Paced ISO 13485:2016 Foundation Training 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.

Course Snapshot

  • Course Duration:

    8 Hours
  • Format

    Online & Self-Paced Course
  • Accreditation

    CQI and IRCA approved training partner
    CQI & IRCA Certified (No. 2327)
  • Delivery Options & Discounts

    • Multi-Person Discount: Book 3 & get a 4th License FREE!
    • More Discounts Available for 10+ Licenses
  • Price

    395 + €25 CQI & IRCA Certification Fee
  • 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

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

CQI & IRCA Certified Course (No. 2327)

Start DateLocationCostHoursActionsVolume License


€ 395
( + €25 CQI & IRCA Certification Fee )
  • 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)

CQI-IRCA-Certified-Course-logoThis course is fully certified by CQI & IRCA (Course No. 2327)

Successful completion will entitle each Learner to receive a Certificate of Completion.


  • I was very pleased with the training course. Thank you to all the team

    Shannon Wilson | January 1, 2021

  • the training was lively and interesting and really tested ones knowledge

    Declan Reynolds | December 17, 2020

  • Course was very informative and read very well I have a very clear understanding of ISO 13485 as a result

    Brian Purtill | December 8, 2020

  • I really enjoyed this course. The content and layout made understanding the ISO 135852016 standard easy.

    Olivia Rice | December 8, 2020

  • Overall training experience very good. The course coordinators Breda Eoin are very interactive and involved.

    Ciara St. Ledger | December 3, 2020

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    Annette Kinsella | December 1, 2020

  • I highly recommend Comply Guru. The course content was excellent and there was a mix of videos knowledge checks and slides as part of the course. The communication process around the course was also excellent.

    Eithne Deacy | November 30, 2020

  • The training experience was very good for a foundation course it really targeted the main points of the standard and explained the intent of them.

    Marguerite Ryan | October 30, 2020

  • The course was very good and provided a clear and concise overview of the requirements of the standard

    Darren Knight | October 20, 2020

  • I have really enjoyed the ISO 134852016 Training Course. It was very insightful and very well organised. I would highly recommend this course.

    Mehmet Hascan | October 11, 2020

  • The interactive classes and practical learning were excellent.

    Estela Hardisty | October 1, 2020

  • Really well balanced delivery of material between varying speakers and slides easy to follow. Very informative in the links and common misinterpretations between clauses. Provided a strong foundation of the standard that would be useful to individuals at all levels of the organization.

    Charlotte Dugdale | September 30, 2020

  • Loads of information - great course. Knowledge assessments at the end of each module was excellent . Well structured course.

    Ashweni Narendra | September 30, 2020

  • Kevin Claffey | September 21, 2020

  • Really enjoyed this course learned a lot of new stuff from it. Would recommend it to anyone.

    Caroline Forde | September 16, 2020

  • Overall training experience was exceptional.Everything from course setup right through to course delivery duration and content was excellent. The presenters did a fantastic job at keeping the focus and attention and explained everything so clearly. I would highly recommend Comply Guru especially the Online ISO 134852016 Foundation Course to anyone looking for a jump start into quality or for someone who just wants to gain a better understanding of the ISO134852016 standard

    Cormac Mac Liathain | September 14, 2020

  • I have worked in the medical device sector for 10 years and took this course as refresher training and can honestly say it was very impressed it was very well put together with intelligent assessment questions overall a very good experience. I really think that people with all levels of experience would benefit from this course I certainly learned a lot.

    Raymond Delany | September 14, 2020

  • Excellent course informative well-paced well designed in course activities to aid understanding and learning.

    Olivia McDermott | September 11, 2020

  • This course is really good. There is a perfect balance between presentations and writen content. The different knowledge checks over the course are really useful. I deeply recommend this course.

    Melody Labrune | September 10, 2020

  • The mix of video and test presentation is very good and well balanced. The ongoing learning recheck and assessment ensures a better understanding of each section and creates a good awareness of progress.The flexibility of being able to start leave and come back is ideally suited to the busy world of work whether from home or in the office. The ongoing support and communication from Comply Guru is another plus. I would have no hesitation in recommending Comply Guru for this and other Quality Courses.

    Gerry McNamara | September 9, 2020

  • My overall experience with Comply Guru is very good there was a huge amount of information in the course some provided by videos which made it easier to follow. I found the scenario type questions very beneficial.

    Aisling Hassett | September 8, 2020

  • Thank you very much for the well structured guidance through ISO 13485

    Gunther Burgstaller | September 7, 2020

  • I felt that this was a very informative training. I liked that each part of a module was short enough for you to keep focus and that there were quizzes after a part and module. I know that its difficult to speak about an ISO in an interesting way but the video speakers could have been a little more outgoing. I really enjoyed the visuals outlines and auto speaker.

    Ashley Sekulich | September 7, 2020

  • Very pleased with this course. The design of the course is exceptional with varied training methods used throughout. this helps to break up the topic and avoid fatigue. I loved the little quizzes throughout the course. I also liked that I could click certain options to see further information- this allows the course to be tailored to the level of knowledge of the participants.

    Angela O'Sullivan | September 4, 2020

  • The training offers essential terminology and info on ISO 13485 requirements. The unique delivery style of remote onsite instructor-led training and computer-evaluation is perfect. I would recommend the flexibility of its modular approach allowing completion of an 8 h course when in FT-employment.

    Aidan Toner | September 4, 2020

  • Great to see a foundation course available for this topic the online format of training gives the flexibility to complete over short periods of time if necessary max 1 hour training in a module. The information given is beneficial and also given in a self intuitive style with further support available as necessary. I would definitely recommend this course.

    Pauline McManus | August 31, 2020

  • Very helpful course great for anyone looking to increase their understanding of ISO 13485

    Emma O'Brien | August 31, 2020

  • I completed the online ISO 13485 Foundation course. I found the delivery clear concise easy to use interesting I can say I know a lot more about the various clauses of ISO 13485 now than I did before this course. Highly recommended.

    Robert Casey | August 31, 2020

  • I found the course very worthwhile and gives a good base knowledge of the ISO.

    Tim Cully | August 20, 2020

  • I enjoyed the course a lot. It was well structured and easy to follow. The course provided a number of best practices and crucial activitiespoints on top of the ISO13485 requirements.

    Kean Beng Ho | August 19, 2020

  • Overall the course was good informative and expanded my knowledge The assessmentsknowledge checks throughout the course were very helpful.

    Liona Carroll Crowley | August 17, 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 online 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 that makes all the difference.

    Brian O'Connell | August 11, 2020

  • 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

  • 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 two final assessments (Part 1 & Part 2). Successful completion will entitle each Learner to receive a certificate of completion.
  • instructimg
    Breda Kearney

    Breda leads the design of Comply Guru’s internationally accredited CQI & IRCA Certified Online & Blended Training Programs.

    Read More

  • instructimg
    John Collins

    John has over 20 years’ experience as a Quality Professional & is a specialist in Quality Management Systems.

    Read More

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 (Recommended)

  • 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.

Printed Copy of ISO 13485:2016 (Required)

  • 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 would 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™

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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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