The only EU MDR course developed from the perspective of an auditor for one of the toughest Notified Bodies on the market, plus, our team of consultants has helped companies prepare for Notified Body audits.
You’ll impress your colleagues and employer with your in-depth knowledge of the ins and outs of both sides.
Certificate Course (Online)
Gain the knowledge, clarity, and confidence to implement the EU MDR (2017/745) regulation, and ensure the Quality Management System and resulting products are compliant and conformant to the EU MDR (2017/745) regulation.
EU Medical Device Regulation (EU MDR) course for professionals, designed with your busy schedule in mind.
How to verify conformity to EU requirements
What applies to your device and why
How to adapt to new process-focused requirements
What you need to know to effectively transition your system
We go beyond simply reading the regulations. We break them down into easy-to-digest sections to ensure competence and confidence upon course completion.
Plus, you'll get access to practical tools that you can use immediately.
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Certified EU MDR Trainer
When it comes to competence, course delivery and trainer experience matters. MDR Consultants offers the only online training course designed from the unique perspective of a Certified EU MDR Trainer with experience as a Biomedical Engineer, Lead Auditor for Notified Bodies including BSI & SGS, Consultant, and a former member of industry.
I founded MDR Consultants during my 17-year career in the medical device and regulatory field, where I gained experience in several roles as a Consultant, Engineer, Lead Auditor, and Certified Trainer for Notified Bodies including BSI and SGS. As a former member of industry, I believe our training programs deliver a learning experience that other companies simply cannot.
Why?
Because other courses offered by companies like BSI are limited in what they can discuss due to conflict-of-interest laws.
So, in other words, you’re not getting the full picture because they are not allowed to talk about specific solutions or methods for implementation. They can only reiterate the information in the regulation.
Our courses are developed from expertise in BOTH sides: as an auditor for one of the most challenging Notified Bodies in the market, AND as a consultant who has prepared companies to face audits against Notified Bodies, so you can be sure you'll get the most comprehensive training and guidance available.
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Professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles.
If you sell or plan to offer medical device products or related services in the EU, this course is for you.
Understand EU MDR (2017/745) so you can ensure products are compliant from phase one of design.
Any company or individual with a role in supply chain management, import, export, distribution, and logistics related to products sold in the EU.
Want more details? Want to make sure this course is the right fit for you?
Contact a course advisor:
📞 (786) 306-0227
✉️ info@mdrconsultants.com
CONTACT US
★★★★★
Krystal and I really enjoyed your course today! Thank you for your time.
★★★★★
I chose this course [EU MDR 101] because it was designed by someone with hands-on experience with implementing EU MDR 2017/745 AND as an auditor for one of the most challenging notified bodies in the market.
★★★★★
We appreciate the information. It sure gives us a clear picture of addressing the complexities of the new regulatory environment under EU MDR. Thank you!
★★★★★
I appreciate all your help these past few weeks. It’s been a great help in preparing us for the audit this week.
