Online Introduction to ISO 13485:2016 Training

★★★★★
(84 Reviews, Click to view)

Overview

This online, self-paced course is ideal for those looking to gain an introduction to ISO 13485:2016. Check it out!

  • 1.5 Hours
Online Introduction to ISO 13485:2016 Training

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

Start Date Location Cost Hours Actions Volume License
Anytime

Anywhere

  € 145 1.5Hours
  • 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)

    In this module an overview of the internationally recognized Medical Device Quality Management System standard ISO 13485:2016 will be provided.

  • Module 2 - Planning and Implementing the QMS (Online & Self-Paced)

    In this module an overview of the requirements related to planning and implementing the QMS will be provided.

  • Module 3 - Checking and Improving the QMS (Online & Self-Paced)

    In this module an overview of the requirements related to Checking and Improving the QMS will be provided.

  • Module 4 - Certification/Registration Process (Online & Self-Paced)

    In this module an overview of the Certification/Registration process will be provided.

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 achievement.

  • Good summary course overview.

    Martin Crehan | April 3, 2020

  • Very professional only small issue I had was with evaluation form....toggling down through the questions it tended to take too big a jump in places.....small issue I know but its easily fixed.

    Brendan McKeon | April 2, 2020

  • Really good exercise and knowledge.

    megha bhapkar | March 14, 2020

  • Very concise and to the point a great way to learn.

    John Grace | February 27, 2020

  • The free online course was a perfect introduction into ISO 134852016.

    Helena Cullen | February 26, 2020

  • Very user friendly experience good content and excellent support available.

    Sean Dolan | February 14, 2020

  • It was a well constructed course to overview the subject and the tests confirmed that one was taking it in

    Dave Taylor | February 13, 2020

  • It was a well constructed course to overview the subject and the tests confirmed that one was taking it in

    Dave Taylor | February 13, 2020

  • It was a well constructed course to overview the subject and the tests confirmed that one was taking it in

    Dave Taylor | February 13, 2020

  • Not as scary as expected

    Alan McKiernan | February 13, 2020

  • It was a well constructed course to overview the subject and the tests confirmed that one was taking it in

    Dave Taylor | February 13, 2020

  • Very well presented and easy to follow.

    Paul Gill | February 4, 2020

  • It was a very helpful course and I would recommend it to others.

    Stephen Holmes | February 4, 2020

  • Very helpful and informative.

    Jonathan Bennett | February 4, 2020

  • I think the format is excellent. Being able to do a module and come back to finish another is very helpful

    Alan Quinn | February 4, 2020

  • The system is user friendly well documented and fulfils the training objective.

    Tom Ward | February 4, 2020

  • Great product

    Marilla Keating | January 27, 2020

  • Great introductory course. Ver clear and concise. Thank you.

    Assumpta Doherty | January 27, 2020

  • Very satisfactory experience.

    Cathal Duignan | January 27, 2020

  • NA

    Gary Scanlon | January 21, 2020

  • The course was brilliant! So simple and complex in the same time. Touches the most important parts of the standard. And for me as a foreign person used language was so easy to understand (I mean both: the wording used and the accent).

    Paulina Wozniak | November 20, 2019

  • The training was informative and helpful. As a suggestion it would be nice to get wrong answers corrected and shown where the error lies to improve your knowledge.

    Miriam Heinlein | November 20, 2019

  • I had a positive experience. The information was clearly presented and one could learn at ones own pace. I also liked the questions at the end of each part. That way one could check whether one was concentrated enough and whether one could remember the things just learned.

    Kai Harting | November 15, 2019

  • Great refresher.

    Angela Lawrence | October 21, 2019

  • Very nice experience. Webinar well structured.

    Chiara Capitani | October 2, 2019

  • The training was great!

    Angela Boykin | September 27, 2019

  • Thanks .

    Muhammad Noman Ur Rehman | September 10, 2019

  • the knowledge gained from this course has been very beneficial as i now understand why we have standards and the reasons for them to be in place. the instructor was very pleasant and very helpful

    Colm Dardis | September 9, 2019

  • I will be able to become competent in structuring, planning and undertaking internal audits.

    Aishling Dermody | September 9, 2019

  • very happy with the course content just see my comment above regarding the final assessment

    Niamh Healy | September 2, 2019

  • I think this is a very good introductory course for those new to ISO 13485:2016 that would benefit people joining medical device companies (i.e. as part of induction training) who are not from a quality background or taking on quality/regulatory specific roles (engineers, production operators, etc.). The strengths I see are: - Provides a good overview of ISO 13485:2016 requirements and benefits - Gets across the importance of complying with the standard - Good/more engaging to see video of the trainer in the slides - Length of time to complete is reasonable (not to short and not too long)

    Mark Moynihan | August 17, 2019

  • There were problems when tried to login. Except for that, the course structure and explanation were awesome. Thanks.!!

    Praveen Nori | August 16, 2019

  • Training was very well laid out. It would be ideal to roll out initial ISO 13485:2016 training at a site going for accreditation to this standard. This provides an excellent alternative to class room training.

    Brendan McLaughlin | August 15, 2019

  • Very resourceful

    L. G. H. Nuranga Avinda | July 10, 2019

  • Great course with lots of information and well structured

    Alvin Liu | July 4, 2019

  • It was good. But the certificate generation takes too long.

    Nayana Tusamda Wakhloo | July 1, 2019

  • It is a nice initiative by the organization.

    Prateek Goyal | July 1, 2019

  • -

    Tom Russell | June 29, 2019

  • good intro

    Kerrie Anderson | June 27, 2019

  • Comply Guru gave a good level of detailed information which was well presented. The information was broken down into short sessions per module which make it easy to find sufficient time to apply. The evaluation at the end of each session ensured that learning was achieved.

    Pauline McManus | June 27, 2019

  • It was very well designed and maintained the interest of learner.

    Kumar Saurabh | June 27, 2019

  • I'm satisfied with the trainings I got from Comply Guru. It definitely increased my knowledge in Management Systems particularly for Food and Medical Systems.

    Mary Rose Lyn Carcasona | June 27, 2019

  • Very nice and very informative

    Olga Petrenko | June 26, 2019

  • Excellent introductory course. I highly recommend this course for a good overview of ISO 13485.

    Tom Doan | June 26, 2019

  • The course gave me a clear idea about the Introduction to ISO 13485:2016. It was easy for me to receive this training experience whenever I have free time. Looking forward to advanced courses related to this topic which sets a career pathway in Quality and Regulatory.

    Bala Amala Kannan | June 26, 2019

  • Easy to understand. Well structured

    Jasbeer Hossen | June 26, 2019

  • Excellent introductory course. I highly recommend this course for a good overview of ISO 13485.

    Parameswaran Nampoothiri | June 26, 2019

  • Very useful introduction to ISO13485.

    Mark O'Sullivan | June 26, 2019

  • The course gave me a clear idea about the Introduction to ISO 13485:2016. It was easy for me to receive this training experience whenever I have free time. Looking forward to advanced courses related to this topic which sets a career pathway in Quality and Regulatory.

    Terrish Floyd | June 26, 2019

  • I am very satisfied with the online training because it gives a good illustration of the course outline and a better understanding of the Standard.

    Festus Osahon | June 26, 2019

  • Excellent

    Virginia Mota | June 26, 2019

  • It focused on the important points that is needed to know. No unnecessary information and wasting of time during the course, kept me focused.

    Nicole Ashcroft | June 26, 2019

  • Excellent course, easy to understand and access. Comply Guru offer great support and quick responses to any queries.

    Elena Feeney | June 26, 2019

  • Excellent course, easy to understand and access. Comply Guru offer great support and quick responses to any queries.

    Kevin Long | June 26, 2019

  • Well structured course that provides a great introduction and overview of the requirements of the standard

    Graeme | June 12, 2019

  • This is a great initiative. Really helpful. Thanks a lot.

    Anonymous | June 6, 2019

  • Given a good overview of ISO 13485:2016

    Megha | June 6, 2019

  • Very knowledgeable and illustrated course

    Anonymous | June 5, 2019

  • Simple easy to understand modules. Videos are helpful

    Anonymous | June 3, 2019

  • Well done

    Anonymous | May 29, 2019

  • The course gave basic idea about ISO 13485:2016

    Anonymous | May 28, 2019

  • A great, easy to follow course. Thank you for translating ISO into plain English!

    Nicole Ashcroft | May 15, 2019

  • it was very helful and structured.

    Nayana Tusamda Wakhloo | May 7, 2019

  • Thank you!

    Ewa Mariethoz | May 4, 2019

  • Great videos and easy to understand.

    Anonymous | May 3, 2019

  • Great starting point to dive into ISO 13485:2016.

    Stanislav | April 26, 2019

  • Very nice course in order to gain a general overview

    Anonymous | April 1, 2019

  • Good introduction course

    Mark | March 20, 2019

  • very informative course

    Anonymous | March 19, 2019

  • Nice introduction to medical device quality systems

    Hakan | March 12, 2019

  • Great awareness.

    Parameswaran | February 26, 2019

  • Very informative and well laid out

    Alvin | February 25, 2019

  • very informative course

    Anonymous | February 17, 2019

  • Simple and easy to understand

    Shobha | February 14, 2019

  • An excellent foundation course

    Kevin | February 12, 2019

  • very informative and easy to follow course!

    Anonymous | February 12, 2019

  • Good content, thorough introduction to fundamentals.

    Anonymous | February 11, 2019

  • Good overview and introduction to ISO 13485:2016, ideal for use along side reading of the standard for better understanding.

    Anonymous | February 11, 2019

  • Nice and clear

    Kerrie | February 7, 2019

  • Course well designed. Easy to follow

    Jasbeer | February 5, 2019

  • Quite useful

    Tom | February 1, 2019

  • Informative

    Anonymous | January 31, 2019

  • Good introductory course that gives a top level insight into ISO 13485 requirements.

    Pauline | January 25, 2019

  • Very good course. It is clear and well structured.

    Anonymous | January 21, 2019

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.

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)