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

Image

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

Image

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

Image

DoC and CE Marking

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

Image

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.

Image

Certified Excellence

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

Image

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

What You'll Learn

Click or tap on each card below to view more details

EU legal framework

  • Entry into Force, Date of Application, Transitional Provisions, and Grace Period
  • CE marking
  • EU Market Product Release Process
  • Legal framework on Release of Regulation 2017/745
  • Structure of the Regulation
  • European Commission Objectives
  • Top Level Review of the Regulation
  • Responsibilities

Scope

  • Intended Purpose
  • Definition of Medical Device

QMS

  • Quality Management System Requirements
  • ISO 13485
  • ISO 14971
  • Language Requirements
  • Commons Specifications and Standards
  • MDCG Guidance Documents
  • Strategy for Regulatory Compliance
  • Competence of Persons and Authors
  • Liability Insurance
  • Certificate of Free Sale

Risk Class

  • Device Class
  • Device Risk Classification

Conformity Assessment

  • Pillars of Technical Documentation
  • Conformity Assessment
  • Routes to Conformity
  • Quality System Based Assessment Annexes
  • Product Based Assessment Annexes
  • Assessment Route Considerations

GSPRs

  • General Safety and Performance Requirements
  • General Requirements
  • Types of Information Supplied with the Device
  • Clinical Evaluation
  • Clinical Investigations
  • SSCP

Technical Documentation

  • Content and General Requirements

Apply

  • MDR Designated NBs and MDR Codes
  • NB Conformity Assessment
  • Additional Procedures
  • Certificate Scope
  • SRN, UDI, EUDAMED

Marking

  • DoC and CE Marking


PMS+

  • Post Market Surveillance and Updates
  • Post Market Surveillance
  • PSUR
  • Post Market Reports
  • Plans needed under the MDR
  • Vigilance
  • Actions of Competent Authorities after Report
  • FSCA and FSN
  • Grace Period and Significant Changes


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!

Noemi

I appreciate all your help these past few weeks. It’s been a great help in preparing us for the audit this week.

FAQ

Have questions?

  • RA, QM, and QA professionals
  • Medical device industry employees
  • Consultants
  • Auditors
  • Regulatory personnel
  • Purchasing department personnel
  • Employees of companies that provide contracted services to Medical Device Manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized representative, importer, distributor, testing house
  • Clinical research professionals conducting trials of medical devices on devices in the EU or planned devices to be placed into the EU market
  • Contract Research Organizations
  • Individuals seeking work opportunities in the medical device industry
  • Employees of a contract manufacturing company
  • Any service provider for the medical device industry
  • Anyone who is part of the supply chain
  • Managers
  • CEOs
  • CFOs
COURSE CONTENT
  • Preface:
    • Welcome and Introduction
    • Course Objectives
    • Course Content and Structure
    • Course Materials and Format
  • EU legal framework:
    • Entry into Force, Date of Application, and Transitional Provisions
    • CE marking
    • EU Market Product Release Process
    • Legal framework on Release of Regulation 2017/745
    • UKCA mark
    • Structure of the Regulation
    • European Commission Objectives
    • Top Level Review of the Regulation
    • Responsibilities
  • Scope:
    • Intended Purpose
    • Definition of Medical Device and Accessories
  • QMS:
    • Quality Management System Requirements
    • ISO 13485
    • ISO 14971
    • Language Requirements
    • Commons Specifications and Standards
    • MDCG Guidance Documents
    • Other Requirements:
      • Strategy for Regulatory Compliance
      • Competence of Persons and Authors
      • Liability Insurance
      • Certificate of Free Sale
  • Risk Class:
    • Device Class
    • Device Risk Classification
  • Conformity Assessment:
    • Pillars of Technical Documentation
    • Conformity Assessment
    • Routes to Conformity
    • Quality System Based Assessment Annexes
    • Product Based Assessment Annexes
    • Assessment Route Considerations
  • GSPRs:
    • General Safety and Performance Requirements
    • General Requirements
    • Types of Information Supplied with the Device
    • Clinical Evaluation
    • Clinical Investigations
    • SSCP
  • Technical Documentation:
    • Content and General Requirements
  • Apply:
    • MDR Designated NBs and MDR Codes
    • NB Conformity Assessment
    • Additional Procedures
    • Certificate Scope
    • SRN, UDI, EUDAMED
  • DoC and CE Marking
  • PMS+:
    • Post Market Surveillance and Updates
    • Post Market Surveillance
    • PSUR
    • Post Market Reports
    • Plans needed under the MDR
    • Vigilance
    • Actions of Competent Authorities after Report
    • FSCA and FSN
    • Grace Period and Significant Changes
  • Additional Information
Yes, students will receive a “Certificate of Completion” issued by an EU MDR 2017/745 Certified Trainer.
This self-paced course is delivered only in our secure student learning portal. Learners will be granted immediate access to the online course upon registration. It is possible to complete the course and obtain your certification in as little as 2 days.
Students will get lifetime access to the online course in the student learning portal, supplemental resources, a copy of the student handbook, a “Certificate of Completion” issued by an EU MDR Certified Trainer upon completion, exclusive access to MDR Consultants advanced training course catalogue (fees for advanced courses not included), and access to MDR Consultants one-to-one consultation packages to assist you with planning your transition to the EU MDR (2017/745) Regulation (additional fees for one-to-one consulting apply).
On average, most students complete the course in 2 days. This online course is self-paced, so you can take as much or as little time as you need to complete. Remember – you also get lifetime access to the student portal, so you can come back to the course content anytime for a refresher!
This course is currently offered in English only.
Yes, we do! As this course is delivered by an EU MDR Certified Trainer, in most cases employers will cover the cost of this course. You can download the information package here: EU MDR Trainer Qualifications Package EU MDR Trainer Qualifications Package
No – your course fee covers all of the materials you need to successfully complete the learning objectives.
Yes! Please contact us to tell us more about your needs: info@mdrconsultants.com

© 2023 MDR Consultants Inc. All Rights Reserved.

© 2023 MDR Consultants Inc. All Rights Reserved.