EU MDR Lead Auditor Training for the European Medical Device Regulation (2017/745)

Blended learning is a hybrid methodology where learners first complete eLearning modules on the underlying theory in advance of Live Workshops facilitated by an experienced Instructor.

This introduces more flexibility vs traditional learning by reducing ‘fixed’ classroom hours by up to 50%. In addition, improved learner confidence & preparation from the eLearning leads to better learning outcomes during the skills-based workshops.

Yes, very practical. Our live workshops are based on the principles of Accelerated Learning (AL). AL is based on ‘learn by doing’ through practical training methods which include real-world examples, case studies, facilitated exercises and group discussions.

We are passionate about ‘No Death by PowerPoint’ or a ‘sit and listen’ methodology. In fact, there are no slides during the live workshops. Come prepared to be fully engaged and of course, to learn a lot!

Yes, we can deliver training in-person or onsite for in-company groups. However, all our public training is delivered virtually. If you prefer in-person training, get in touch, we are happy to help.

Yes, we offer in-company (private) training provided you have 5 or more learners that can be trained together on the same dates. Please request a quote and a member of our team will be in touch to discuss this further with you.

The eLearning unlocks up to 30 days in advance of the scheduled workshop(s). This is intentional. The modules are designed for learning to be achieved in the weeks leading up to live workshop(s) to ensure continuity in learning.

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.

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

Yes, we permit substitutions provided the license has not been activated, the substitute meets the entry criteria and there is sufficient time available for the replacement to complete the mandatory eLearning and assessments. There is no fee for substitutions.

If the workshop is delivered virtually, there will be a link on your Learner dashboard. This link will become a visible two days in advance of the start date. In addition, a calendar invite is issued.

The eLearning modules, including assessments, form a mandatory part of the training. To be eligible to attend the live workshop(s), these must be successfully completed in advance of the specific deadline date for your registered workshops(s).

Note: if the eLearning modules and assessments are not successfully completed by the deadline, you will not be eligible to attend the live workshops. No refunds are possible when you fail to complete the eLearning on time.

Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.

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.

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 an estimate based on the average amount of time it takes a learner who is new to the subject/topic. In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.

Once you have fully attended the live workshop(s) and passed the assessments you will be able to register for the lead auditor exam via your learner dashboard by selecting one of our scheduled exam dates. The exams are attended remotely.

Lead auditor exams must be graded by two examiners, and the process takes up to 30 days to be completed.

Yes, you can reschedule your exam. This can be done via your learner dashboard. We require a minimum of 48 hours’ notice to reschedule.

If you are unsuccessful in your first attempt, you will be able to schedule a resit exam. There is a limit of 1 resit available. If you are unsuccessful in your second attempt, you would need to re-register and re-complete the full training, plus a new exam (subject to additional fees).