ISO 13485 MDMS Training Courses
|ISO 13485 Internal Auditor||To conduct effective internal audits||Online||12 hours|
|ISO 13485 Internal Auditor Refresher||To update current certification||Online||8 hours|
|ISO 13485 Internal Auditor Extension||To add to current certification||Online||8 hours|
|ISO 13485 Lead Auditor||To programme and conduct internal audits||Online||36 hours|
|ISO 13485 Lead Auditor Refresher||To update current certification||Online||27 hours|
|ISO 13485 Lead Auditor Extension||To add to current certification||Online||27 hours|
|ISO 13485 Lead Implementer||To implement and maintain an MDMS||Online||30 hours|
|ISO 13485 Consultant and Lead Auditor Diploma||The premier MDMS Consultant qualification||Online||36 hours|
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INFOGRAPHIC: ISO 13485 Course Selection
Courses have been updated February 2022
Our Courses have been updated to include …
- Introduction to Regulations and Guidelines – EU, UK and USA
- Annex ZA and ZB of ISO 13485:2016 Amendment 11
ISO 13485 Overview
What is ISO 13485?
ISO 13485:2016, the latest version of the ISO 13485 standard, is an internationally-recognized standard that sets out the requirement for a Medical Device Management System (MDMS).
It was initially published in 1996 as ISO 13485:1996 and revised in 2003. Associated standards since replaced by ISO 13485 include ISO 13488, EN 46001 and EN 46002. The current standard has been adopted by the EU as a harmonized standard with the title EN ISO 13485:2016.
EN ISO 13485:2016 is identical with ISO 13485:2016, sometimes referred to as the international version, except for the addition of 3 Annexes related to EU Directives. Do note that these Annexes are now out-of-date as they do not correspond with the current EU Medical Device Regulations (EU Regulation 2017/725 for medical devices and EU Regulation 2017/726 for in-vitro medical devices).
What is ISO 13485 Training?
ISO 13485 involves training programs designed to equip auditors, lead implementers, quality managers, and other management system professionals with the necessary skills and knowledge to develop, implement, maintain, or audit Medical Device Management Systems and ensure their compliance with the requirements of ISO 13485.
Is this training mandatory?
Yes and No.
Management Representative or other professionals with day-to-day responsibility in maintaining an MDMS are not required to undergo ISO 13485 training. It is instead implied as already part of developing competence. It is not a specific stand-alone requirement.
That said, ISO 13485 training is strongly recommended as effective internal audits are essential to doing a professional job in maintaining your Medical Device Management System and preparing it for Certification Body audits.
How Can I Enroll in an ISO 13485 Training Course?
You can enroll in any of deGRANDSON’s online training courses by going to the product page of the course you want to enroll in. Once there, add the course to your cart and then proceed to checkout and payment.
Once you’ve paid for the course, you will be asked to provide the email address or addresses of the people who will be enrolling in the course. They will then receive an email providing the username and password they would need to access deGRANDSON’s Learning Management System where the training is delivered.
Please see this video to see a more visual demonstration of the enrollment process.
Need more information on ISO 13485 Certification?
Check out our answers to Frequently Asked Questions. Just click this image …
Here you'll find the ISO 13485 Training Course you want
Your specific situation will determine which is the best course for you.
This 12-hour ISO 13485 Internal Auditor training course is the course you need to become a certified internal auditor and be qualified to perform internal audits.
I'm newly responsible for my organization's Medical Device Management System. Which course should I take?
Quality Managers who don’t feel confident about ISO 13485: 2016 and its requirements are suited for this ISO 13485 Lead Implementer course. It will help you understand what an efficient and effective Medical Device Management System looks like.
We manufacture medical device components. I've been tasked with getting our ISO 13485 certification. Which course should I take?
Our 30-hour ISO 13485 Lead Implementer course is ideal for you. You may need some consultancy support on implementation, but that should be limited. Furthermore, you’ll know the ‘right’ questions to ask.
Implementing a Medical Device Management System yourself can be challenging. However, it’s a great way to quickly introduce changes needed to secure and retain ISO 13485 certification.
I'm a Medical Device Management System Lead Auditor and want to upgrade to the new Standard. Which course should I take?
Update your Lead Auditor certification to the latest standard with this 24-hour ISO 13485:2016 Lead Auditor Conversion Course.
I'm already a Lead Auditor and I'd like to add ISO 13485:2016 to my auditor certification. Which course should I take?
This 24-hour ISO 13485 Lead Auditor Extension course will let you add ISO 13485 to your lead auditor certification.
This ISO 13485 Lead Auditor course provides in-depth knowledge of the Standard and of Auditing skills. This is the certification you need if you hope to audit for a Certification Body.
We're certified in the old standard. Now, I want to upgrade our Medical Device Management System to meet the ISO 13485: 2016 requirements. Which course should I take?
This Transition Training package includes an ISO 13485: 2016 Implementation Handbook. Packed along with it is a documentation toolkit, lots of sample paperwork, and a Gap Analysis Tool.
This 30-hour ISO 13485 Lead Implementer course includes a 33-step Path to Certification, a 100+ page ISO 13485: 2016 Implementation Handbook.
It also includes a Documentation Toolkit that contains sample SOPs and record forms. Examples of audit schedules and management review agenda are included as well. Truly beneficial to a new MDMS consultant.
I'm a Medical Device Management System Internal Auditor and need to learn about the revised Standard. Which course should I take?
Upgrade your ISO 13485 internal auditing skills in accordance to the latest revision with this 8-hour ISO 13485:2016 Internal Auditor Refresher Course. Moreover, you can get it at a fraction of the usual time and cost it takes to finish the course.
This 8-hour ISO 13485 Internal Auditor Extension Course will let you add ISO 13485 to your internal auditor certification.
You may also like:
To see an overview of our Training Courses please visit our Home Page.
If you’re an ISO Auditor seeking to add new standards to your certification, check out our Extension Courses.
For ISO Auditors wishing to update their certification to newly revised ISO Standards, see our Conversion Courses.
And for those who need to migrate a Management System to a newly revised ISO Standard, see our Transition Course
Internationally Recognized Certification
Our ISO 21001 Educational Organization status is shown on all Certificates we issue.
Satisfied Customers Say:
There were a few minor issues with course content integration with course software, however, Customer Service through the Support Ticket was quick to respond and address issues. The ability to learn and gain qualifications through an online platform such as deGRANDSON’s offer is an extremely flexible option. I would commend this learning option and the use of Safari iOS which works consistently with the learning platform. The Support Team are very efficient and quickly resolves any issues that might be encountered, many thanks.
This is an excellent course. The content in the 3 modules was so beneficial and helped me to grasp details that I had previously struggled with. It was evident that the content was factual and from the real world in its tips for application. The answers and direction provided in the FAQ’s was excellent and very helpful. Any query I had was answered promptly. I honestly don’t know what you could do better. Thank you for all your help and guidance.
Course states 24 hours, I would say it took double that time to complete. Had some technical difficulties but Ultan King in support has been very helpful in resolving all issues.
Have only completed the first part of the course, enjoying it immensely, so far. the content is thorough and clearly explained. I only have one small observation – that it may be better using a real person, or even person(s) to present rather than a computer generated voice which can be a little wearing over time.
David Vickers(Private Learner)
Cost / learning is really adapted. You can progress with adapted elearning at your rythm
Benoît F.(Private Learner)
I’m extremely pleased with my ISO 45001 Lead Auditor course from deGrandson that I started in February 2021. I work for Amazon as a Construction Manager constructing fulfilment centers in the UK, EU and worldwide. The course material is excellent, the online learning system is very easy to use and the course is very well structured. I highly recommend this course by deGrandson. Dr John FitzGerald is an expert in this subject area and it shows. You will be pleased that you also chose to study with deGrandson.
These are very detailed courses and they work very well for us.
On-line study at my own pace is most suitable learning media to me. The course is timely with the latest 2019 edition of the Standard coupled with value for money package.
Gnana Sakaran Rajagopal (Principal)GSR Consulting Services
All the way through this course I have been extremely impressed with the excellent support that has been in place for students, and this provides confidence that issues are resolved promptly with fair consideration.
Steve Fitzjohn(Private Learner)
Thanks for the great Course, I really enjoyed it.
Neil SmithUkhuselo Management Systems
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