EU MDR 201: Advanced Application & Implementation Process of the EU MDR (2017/745)

This course is a 3-Day Live Online Course designed to equip students with the advanced practical skills expected of a Subject Matter Expert. This course is ideal for learners who have a foundational knowledge or prior training on EU MDR (2017/745).

Course schedule:

August 22: 9 a.m. to 5 p.m. ET

August 23: 9 a.m. to 5 p.m. ET

August 24: 9 a.m. to 1 p.m. ET

Recommended pre-training (optional): EU MDR 101 (2017/745) Regulation Implementation Self-Paced Online Course

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Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market

The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:

If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be placed on the market.
If you have Class I devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and product's technical documentation needed to meet the new EU MDR requirements as of May 26, 2021.
If new products are launching, they are not covered by the MDD and therefore need to be conformant to the EU MDR.

Missing The Deadline Could Mean Losing Access to the ENTIRE EU Market

The deadline to transition to the EU MDR is May 26, 2024, but many companies have already missed important dates:

If your products are certified under an Annex 4 Directive 90/385/EEC or Annex IV to Directive 93/42/EEC, your certification was voided on May 27, 2022 in accordance with Article 120. Which means your products can no longer be place on the market.
If you have Class 2 devices that are not sterile, do not have a measuring function, or are reusable, then your entire QMS and documentation system needed to meet the new EU MDR requirements as of May 26, 2021.
If new products are launching, they are not covered by MDD

70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?

Here's just a few reasons:

They think that implementation can be completed in just a couple of months because they don't understand the magnitude of the regulation's impact on their day-to-day
They're overwhelmed by the sheer amount of information and complex provisions
Confused about where to begin
Skeptical of the expertise of training instructors
Insecure about their current level of knowledge regarding the regulation.

But we're here to make it easy for you.

70% of the medical device industry has not made the transition to the EU MDR (2017/745). Why?

Here's just a few reasons:

They're overwhelmed by the sheer amount of information and complex provisions
Confused about where to begin
Skeptical of the expertise of training instructors
Insecure about their current level of knowledge regarding the regulation.

But we're here to make it easy for you.

Hi, I’m Isabel Osorio

I have the unique experience of having worked as an Engineer, Lead Auditor and Certified Trainer for Notified Bodies, Consultant, and former member of industry throughout my 16 year career in the MDR field.

I’ve created this course, Advanced Application & Implementation Process of the EU MDR (2017/745)

specifically for those who want a deeper understanding of the practical applications of the regulation. This course is designed to position you as a Subject Matter Expert and leader in your role. This is a live 2-Day virtual course, where you will have the opportunity to ask questions in real-time to ensure confidence and competence upon course completion.

When it comes to competence, course delivery and trainer experience matters.

EU MDR 201 is the only online training course designed from the unique perspective of an EU MDR Certified Trainer with experience as a Biomedical Engineer, Lead Auditor for Notified Bodies, Consultant, and a former member of industry.

Hi, I’m Isabel Osorio

I have the unique experience of having worked as an engineer, auditor and as a member of industry throughout my career. I’ve been a consultant since 2019.

I’ve created Advanced Application & Implementation Process of the EU MDR (2017/745) specifically for those who want a deeper understanding of the practical applications of the regulation. This course is designed to position you as a Subject Matter Expert and leader in your role. This is a live 2-Day virtual course, where you will have the opportunity to ask questions in real-time to ensure confidence and competence upon course completion.

We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.

By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to ensure your Quality Management System and resulting products are compliant and conformant to the EU MDR (2017/745) regulation.

Practical Tools

We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.

Real-world Perspective

Isabel Osorio has the unique perspective of having experience both as an engineer AND an auditor. This means we teach exactly what systems you need in place in order to successfully pass an audit (and how to make them more efficient and less resource-draining).

Reimbursement Opportunities

Also, be sure to ask your employer for opportunities of reimbursement. You may qualify to take the course at no cost to you.

Who Is This Course For?

Engineers

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

Members of Industry

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

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.

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

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

We're connecting the dots for learners in a way that no other course can, with a focus on competence and confidence.

By the end of this course, you will have the knowledge, clarity, and confidence to implement the new EU MDR (2017/745) regulation. You will be prepared to confidently face any audit. You will have a solid understanding of exactly what you need to do in order to implement proper quality test to ensure your devices are compliant and up to code.

Practical Tools

We go beyond simply reading the regulations. We break them down into easy-to-digest parts. Additionally, you will receive practical tools that you can use immediately.