MDR Expert Qualification Program Level 3

The MDR Expert Qualification Program is designed to empower professionals with the knowledge and skills needed to navigate the complex landscape of the European Medical Device Regulation (MDR). This program is meticulously crafted to offer a structured pathway, comprising of three progressive levels, each tailored to elevate your understanding and proficiency in MDR compliance.

The pinnacle of the program, Level 3, offers participants the opportunity to specialize in their chosen field through an instructor-led course on Specialized Requirements under EU MDR. This level culminates with a rigorous qualification examination, combining multiple-choice questions and subjective assessments to ensure participants not only grasp theoretical concepts but can also apply their knowledge in real-world scenarios.

Level 1: Foundation Courses (MDR Essentials 1)

• MDR – Basics Course (Self-Paced)
• Technical Documentation under MDR (Self-Paced)
• Unique Device Identification (UDI) (Self-Paced)
• EUDAMED (Self-Paced)

Level 2: Advanced Courses (MDR Essentials 2)

• Clinical Evaluation Module (Self-Paced)
• Post-Market Surveillance Module (Self-Paced)
• Advanced Requirements under EU MDR 2017/745 (Instructor-Led Course)

Level 3: Specialised Course (MDR Expert)

• Introduction to advanced requirements under MDR
• Case-studies and real-world scenarios for practical application
• Assignments and problem-solving session
• Developing strategies for effective implementation
• Addressing challenges in regulatory submissions based on product classification
• Regulatory updates and emerging trends
• Exploring emerging trends and their impact on MDR Compliance
• Case studies and group discussions
• Key learnings and best practices
• Qualification Examination

• Medical Device Manufacturers
  
• Quality Assurance/Regulatory Affairs Team
• Product Managers
• Persons responsible for the preparation of technical documentation
• Employees from the development and quality assurance department
• Production Team
• Engineering Team
• Medical Device Consultants

• Level 1 courses are aimed at beginners or novices in the industry, whereas level 2 and level 3 courses are aimed at intermediate to advanced learners who have foundational understanding of Medical Devices with industry experience.
  
• Participants are required to complete L1 and L2 courses to be eligible for a L3 qualification from TÜV SÜD.

• Comprehensive Curriculum: Covering all aspects of MDR compliance, from foundational principles to specialized requirements.
  
• Flexible Learning: Self-paced courses allow participants to learn at their own pace, while instructor-led sessions provide interactive and in-depth discussions.
• Real-World Application: Case studies and practical examples ensure that participants can apply their knowledge in professional settings.
• Industry-Relevant Specialization: The program caters to professionals from diverse medical device backgrounds, allowing them to specialise in areas relevant to their expertise.
• Certification: Gain a TÜV SÜD Certified MDR Expert Certification on successfully completing all 3 levels of courses.

• Examination is hosted on an online platform and consists of multiple-choice questions and subjective questions
• Exam duration: 120 minutes
• Passing criteria: 70%

Certification
Learners who pass the final examination are awarded TÜV SÜD Certified MDR Expert completion certificate which mentions that the candidate has passed the examination

1. When can I get the certificate?
MDR Expert Level-3 certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?
One day before the commencement of the training program.

3. How do I pay the fees for training and examination?
Online mode.

4. What are the benefits of the MDR Expert Qualification Program Level 3?
Comprehensive Curriculum: Covering all aspects of MDR compliance, from foundational principles to specialized requirements
Flexible Learning: Self-paced courses allow participants to learn at their own pace, while instructor-led sessions provide interactive and in-depth discussions.
Real-World Application: Case studies and practical examples ensure that participants can apply their knowledge in professional settings
Industry-Relevant Specialization: The program caters to professionals from diverse medical device backgrounds, allowing them to specialise in areas relevant to their expertise
Certification: Gain a TÜV SÜD Certified MDR Expert Certification on successfully completing all 3 levels of courses.

5. Is there any refund policy for the paid fees?
Please refer to Cancellation and Refund policy page.