InstructorRoyed Training
TypeOnline Course
Price$390 USD / 22500 INR.
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eu mdr training course

Introduction

Who should attend

Features

Related Courses

eu mdr training

EU MDR training imparts practical knowledge about the Regulation and registration of various classes of medical device in Europe.

This advanced certification course in EU Medical Devices also covers medical devices strategic management and planning process. Moreover, this course will demonstrate key skills for medical devices business skills  and concepts specifically for EU. Most importantly, The course provides cased based learning. As a result, it is easy for participants to understand the concepts. Above all, this EU MDR training covers updates and changes in the new regulations which is important to learner who want strong foundation in EU medical device knowledge. Most importantly, this course provides walkthrough on the regulatory expectations of European Commission, as well as medical device manufacturers, notified bodies and member state competent authorities. 

In addition, this medical devices regulatory affairs course challenges students and Professionals to apply what they have learned through the use of interactive exercises, reflection questions, and a final assessment at the end of the course.

The course can be completed at any place. So, it allows the user to stop and start at their leisure. 

Moreover, user can access the course at own pace. Hence, it allows the user to stop and start at their leisure. 

  • Course Code: RYD-110
  • Title of the course: Advanced Certification Course in EU MDR (ACEUMDR)
  • Duration of the course: 1 Month
  • Eligibility: Anyone who want to seek knowledge about EU MDR regulation.
  • Nature of the course: Online Self Paced Learning. Course can be accessed online across anywhere 24×7.
  • Course Certificates: Certificate will be provided at the end of the successful completion of the course

Who should attend?

  • This course is ideal for Medical Devices Professionals, who are seeking to improve their skills in the EU MDR environment.
  • Those who are entering into regulatory affairs from other areas within a device company (Pharmacists, Clinical Trials, Marketing and others).
  • This course will be ideal for those working in Quality or Continuous Improvement departments in a medical devices’ industry.
  • Moreover, this course will be beneficial for the regulatory affairs professionals who are working on medical device but do not have working knowledge of the EU medical device.
  • Above all, this course will be great tool to enhance the skills in Business Development and Strategic Planning department in medical device.

Course Features

This online course utilizes 24×7 interactive learning tools to guide each participant through the steps of eu medical devices regulation and marketing authorization process in detail. Moreover, the course challenges students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

Course Deliverables

  1. Attend the course 24×7 by login to your dashboard. So, you can attend lectures, simulation, self assessment tests and final certification examination.
  2. You will also be eligible to receive the course study modules, which you can download by login to your course page.

Important Learning Features of EU MDR training: 

  • Online 24×7 access from anywhere. Hence, one can learn at your convenience.
  • Hence, the course provides timing flexibility. In other words, one can attend the lecture sessions at your own convenient time.
  • Interactive E-lectures helps user to understand of the concepts effectively.
  • Above all, course provides simulation for real life working. Hence, it helps user to apply the decision making skill in real life scenarios.

Medical Devices Course Coverage Area

EU Medical Device Regulations (MDR and IVDR)

An overview of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), including their scope, key changes, timelines, and implications for manufacturers, distributors, and other stakeholders.

Classification of Medical Devices

Understanding the classification of medical devices based on their risk level and how it impacts the conformity assessment process.

Conformity Assessment Procedures

Explaining the different conformity assessment routes for medical devices, such as self-certification, notified body involvement, and the necessary documentation and steps for each.

Technical Documentation

Detailed guidance on creating and maintaining technical documentation, including design and risk management documentation, clinical evaluation reports, post-market surveillance, and vigilance reporting.

Clinical Evaluation and Performance Studies

The importance of clinical data in supporting the safety and performance of medical devices, and how to conduct clinical evaluations and performance studies.

Labeling and Packaging Requirements

Overview of labeling and packaging regulations, including the Unique Device Identification (UDI) system and other labeling requirements.

Post-Market Surveillance (PMS) and Vigilance

How to establish a post-market surveillance system, collect feedback from users, and handle vigilance reporting in case of adverse events.

Quality Management Systems (QMS)

Understanding the requirements of ISO 13485 and how to implement a robust quality management system for medical devices.

Authorized Representative and Importer Responsibilities

For non-EU manufacturers, the role and responsibilities of the authorized representative and importer in the EU market.

UDI Implementation

Guidelines on implementing the Unique Device Identification system for medical devices.

Clinical Investigations and Notified Body Interactions

Explaining the process of conducting clinical investigations and how to interact with notified bodies for conformity assessments.

Market Access and Post-Market Obligations

Procedures for obtaining CE marking, maintaining compliance, and fulfilling post-market obligations.

In Vitro Diagnostic Devices Specific Requirements

Specific requirements for in vitro diagnostic medical devices under the IVDR, including performance studies, performance evaluation, and performance evaluation reports.

Here you can find some medical device training courses for your reference.

Medical Devices Training Courses


Course Code

Course

Duration

RYD-083 (Executive Program)

Medical Device Global Business

1 Year

RYD-077

Drug Biologic Medical Device Regulatory Affairs

1 Year

RYD-006

Medical Devices Regulation

1 Year

RYD-082

US Medical Device Regulation

1 month

RYD-035

CE Certification in Medical Devices

3 Days
Section 1EU REGULATION FOR MEDICAL DEVICES
Lecture 1EU MDR Classification
Lecture 2EU MDD | EU MDR | Articles | Rules | Pages | Annex | Key Changes in EU MDR
Lecture 3EU MDR  | Annexes | Key notes
Lecture 4EU Medical Device Regulation System | MDR | IVDR | UDI | EUDAMED | Requirements for manufacturer | Importer | Distributor | Declaration of Conformity (DoC)
Lecture 5EU MDR Guideline | EU MDR - Annexes 
Lecture 6EU MDR Conformity Assessment procedure | Assessment of various classes and types of the devices | Key points to consider | Conformity assessment master chart 
Lecture 7EU MDR Authorized Representatives | Mandate | Role and Responsibilities
Section 2Labeling Requirements for Medical Devices
Lecture 8Medical Device Labeling Guideline | General Principles | Wherever applicable (specific) Labeling contents 
Lecture 9Instruction for Use (IFU)
Lecture 10UDI | Different Component | How to design  
Section 3QMS, Documentation and Dossier Preparation
Lecture 11Medical Device Technical File
Lecture 12Medical Device Dossier Preparation | Section Wise Dossier Preparation | Key Requirements regarding dossier | Points to note regarding each section of the dossier 
Lecture 13Quality Management System (QMS) for medical devices company 
Lecture 14Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Lecture 15Comparing Medical Device Regulations | 510k Submission | Technical File | Design History File | Design Master File 
Lecture 16Medical Device Essential Principle Checklist | Documentation |  Open file
Lecture 17Implant Card | Regulatory Importance | Content | How to design 
Section 4C-GMP REQUIREMENT FOR MEDICAL DEVICES
Lecture 18c-GMP Requirement for Medical Devices
Lecture 19GMP Exemptions
Lecture 20GMP - Premises & Plant Layout Designing
Lecture 21Sanitation and Hygiene
Lecture 22Equipment Modules
Lecture 23Production Modules
Lecture 24G5 Lecture Documentation
Lecture 25Quality Control
Lecture 26Product Complaint
Lecture 27Storage
Lecture 28Product Recall | Product Withdrawal | Handling and Management of Product Recall 
Lecture 29Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter
Lecture 30Documentation | Good Documentation Practices
Lecture 31ISO and ISO Audits
Lecture 32Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry
Lecture 33Certification and Legal Requirements for Medical Devices | Conformity Assessment Planning
Section 5CE MARKING
Lecture 34Introduction to CE Marking
Lecture 35CE- Self Certification
Lecture 36General principles of the CE marking
Lecture 37Manufacturer Responsibilities
Lecture 38Third Party Medical Device Manufacturing & CE Marking
Lecture 39Classifying Medical Devices Based on the Type of Manufacturing Operation
Lecture 40Understanding Terminologies - OBL/PBL/PLM/OEM/OES
Lecture 41Step By Step CE Marking Process
Lecture 42Case Study
Section 6TECHNICAL DOSSIER
Lecture 43Introduction
Lecture 44Components of technical documentations
Lecture 45Technical Dossier - Information Required
Section 7ISO 13485:2016 : IMPLEMENTATION IN MEDICAL DEVICE ORGANIZATION
Lecture 46Introduction to ISO 13485:2016
Lecture 47ISO 13485:2016 Audit Checklist