Free – Online Introduction to ISO 13485:2016 Training

★★★★★
(64 Reviews, Click to view)

Overview

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

  • 1.5 Hours
Free – Online Introduction to ISO 13485:2016 Training

Some Companies that have used Comply Guru™

Start Date Location Cost Hours Action
Anytime

Anywhere

Free
€ 175
1.5Hours
  • Module 0 - Course Introduction

    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

    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

    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

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

  • Module 4 - Certification/Registration Process

    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.

  • 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

  • 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

  • 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

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

    Aishling Dermody | September 9, 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

  • 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 is a nice initiative by the organization.

    Prateek Goyal | July 1, 2019

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

    Nayana Tusamda Wakhloo | July 1, 2019

  • -

    Tom Russell | June 29, 2019

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

    Kumar Saurabh | June 27, 2019

  • good intro

    Kerrie Anderson | 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

  • 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

  • Excellent

    Virginia Mota | 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

  • 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.

    Kevin Long | 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

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

    Elena Feeney | June 26, 2019

  • Very useful introduction to ISO13485.

    Mark O'Sullivan | June 26, 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

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

    Parameswaran Nampoothiri | June 26, 2019

  • Easy to understand. Well structured

    Jasbeer Hossen | June 26, 2019

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

    Graeme | June 12, 2019

  • Given a good overview of ISO 13485:2016

    Megha | June 6, 2019

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

    Anonymous | 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

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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.

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Custom Course Development

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