Course updated following the EU's publication of Regulation (EU) 2023/607 on March 20, 2023

EU MDR 2017/745 Training designed to set you apart from the competition

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.

The most comprehensive and up-to-date training, guaranteed.

Certificate Course (Online)

Requirements of the EU Medical Device Regulation (MDR) 2017/745 and Implementation Process

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.

SAVE $299 ON COURSE FEES (LIMITED TIME ONLY)

Regulatory Training - Simplified.

EU Medical Device Regulation (EU MDR) course for professionals, designed with your busy schedule in mind.

Learn at your own pace from your laptop or the MDR Academy mobile app
On-demand video course
One-to-one support for Q&A
Use your certificate to showcase your advanced skills to employers; include it in your CV, LinkedIn profile, and job applications

ISO 13485

Used as a baseline for requirements, however, it does not cover local regulations - learn what's covered, what's not, and how to identify any gaps

ISO 14971

The standard for risk management for medical devices - we'll cover everything you need to know to develop a comprehensive risk management plan

DoC and CE Marking

The final steps before market release. You'll learn exactly what is required to ensure a successful application.

SRN, UDI, Eudamed

An in-depth review of additional requirements you need to know to be compliant

And more! This course covers 48 key topics. You'll get the most comprehensive training available, guaranteed.

CE Marking

Legal mark

How to verify conformity to EU requirements

GSPRs

Safety & performance

What applies to your device and why

PMS+

Surveillance & vigilance

How to adapt to new process-focused requirements

QMS

Compliance strategy

What you need to know to effectively transition your system

And more! This course covers 48 key topics. You'll get the most comprehensive training available, guaranteed.

Easy To Digest Modules + Practical Tools

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.

Certified EU MDR Trainer

Trainer Qualifications Directly Affect Your Success

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.

Certified Excellence

Very few EU MDR instructors have met the rigorous standards required to achieve certification.

World-Class Instruction

Isabel Osorio is one of the only Certified EU MDR Trainers in the world.

Hi! I'm Isabel Osorio.

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.

What You'll Learn

Click or tap on each card below to view more details

Who Is This Course For?

Quality Assurance (QA) & Regulatory Affairs (RA) Personnel

Professionals in Regulatory Affairs, Quality Management, and Quality Assurance roles.

Members of Industry

If you sell or plan to offer medical device products or related services in the EU, this course is for you.

Engineers

Understand EU MDR (2017/745) so you can ensure products are compliant from phase one of design.

Supply Chain Management

Any company or individual with a role in supply chain management, import, export, distribution, and logistics related to products sold in the EU.

Still have questions? We're here to help!

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

Testimonials

Jasmin

Krystal and I really enjoyed your course today! Thank you for your time.

Jose

I chose this course [EU MDR 101] because it was designed by someone who has hands-on experience with implementing EU MDR 2017/745 AND as an auditor for one of the most challenging notified bodies in the market.

Chris

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!