ISO 13485 Internal Auditor Training for Medical Device Quality Management Systems (MD-QMS)

Each license is for 12 months. Upon completion, the module content is still accessible for the full duration. However, the assessments cannot be re-completed once successfully passed (or if you exceed 3 attempts).

Each Learner has a maximum of 3 attempts at each assessment. We strongly encourage all learners to review & revise the course content again before each attempt (if unsuccessful on an attempt).

If unsuccessful after a 3rd attempt, you will not be eligible for certification. No refunds are possible due to a failed examination result.

If you register on the website, you will be able to access the eLearning within 1 hour of registering, subject to successful payment. If you are registering via Purchase Order, access will be enabled within 1 business day of payment being received.

Yes, we offer discounts for 5 or more learners on a scale based on the total number at the time of purchase. If you want to enquire about discounts, request a quote using the form on this page and a member of our team will be in touch.

Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.

Please note: no certificates are available without full payment on file.

Yes, we permit substitutions provided the license has not been activated and the request is made within 30-days of the purchase date. There is no fee for substitutions.

Comply Guru do not provide learners with copies of international standards, nor do we require that any purchase is made. However, participants do need to have access to a copy of required standard(s) on this training, if the credential requires it.

Firstly, we suggest seeing if you can obtain a copy of the required standard(s) from a friend, colleague or at your workplace. If you are unable to do so, each country has a nominated ISO standard supplier where you may purchase the international standard(s) you need for your training.

The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.

In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.

Extensions to the eLearning deadline (or license) are reviewed on a case by case basis. If you require an extension, please contact our team outlining your reason for the extension in advance of the expiration. Expired licenses cannot be reactivated or extended.

To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).

All graded assessments are MCQ-based.