MDR Expert Qualification Program

Training Duration: 3 Days

The MDR Expert Qualification Program is a comprehensive, multi-level curriculum designed to build expertise in European Medical Device Regulation (EU MDR) compliance. Level 3 focuses on specialized areas, enabling participants to deepen their knowledge, tackle complex regulatory challenges, and lead successful compliance initiatives. This program combines self-paced and instructor-led coursework, culminating in a rigorous qualification examination that validates your proficiency as an MDR Expert.

What Will You Learn?

Master the foundations and advanced concepts of European MDR compliance.
Specialize in specific MDR requirements relevant to your role and product type.
Apply MDR knowledge practically through case studies, assignments, and problem-solving exercises.
Navigate regulatory challenges including product classification, documentation, and submissions.
Stay current with regulatory updates and emerging trends influencing the medical device industry.
Prepare for and pass the MDR Expert qualification examination, confirming your readiness to serve as a regulatory specialist.

Course Outline

Level 1: Foundation Courses (MDR Essentials 1)
- MDR Basics (Self-Paced)
- Technical Documentation under MDR (Self-Paced)
- Unique Device Identification (UDI) (Self-Paced)
- EUDAMED Overview (Self-Paced)
Level 2: Advanced Courses (MDR Essentials 2)
- Clinical Evaluation Module (Self-Paced)
- Post-Market Surveillance Module (Self-Paced)
- Advanced EU MDR Requirements (Instructor-Led)
Level 3: Specialised Expertise (MDR Expert)
- Introduction to Advanced MDR Requirements
- Practical Case Studies & Real-World Scenarios
- Assignments and Problem-Solving Sessions
- Strategies for Effective MDR Implementation
- Regulatory Submission Challenges by Product Classification
- Updates on Emerging Trends Impacting MDR
- Group Discussions and Best Practice Sharing
- Final Qualification Examination

Who Should Attend?

Medical Device Manufacturers
Quality Assurance and Regulatory Affairs Professionals
Product Managers
Personnel Responsible for Technical Documentation
Development and Quality Assurance Teams
Production and Engineering Staff
Medical Device Consultants
Prerequisites
- Level 1 courses are ideal for beginners or professionals new to the medical device industry.
- Levels 2 and 3 are designed for intermediate to advanced learners with existing knowledge and experience in MDR and medical devices.
- Completion of Levels 1 and 2 is mandatory to qualify for Level 3 certification through TÜV SÜD.

Learning & Career Benefits

Comprehensive Curriculum covering all facets of MDR compliance.
Flexible Learning Format with a mix of self-paced and instructor-led modules.
Practical Application through real-world case studies and interactive discussions.
Industry-Relevant Specialization aligning training with your professional focus.
Certified Recognition through TÜV SÜD’s respected MDR Expert certification, enhancing career prospects.

Examination & Certification

Format: Online exam combining multiple-choice and subjective questions
Duration: 120 minutes
Passing Score: 70% or higher
Certification: Upon successful completion, participants receive the TÜV SÜD Certified MDR Expert certificate, officially recognizing their expertise and qualification.

Get in touch with us to know more.

Business address

TÜV SÜD Bangladesh (Pvt.) Ltd.

Update Tower, Level- 12, 8 & 14, 01 Shahjalal Avenue, Sector-06, Uttara Model Town, Dhaka-1230, Bangladesh

Tel: +88 02 58954115, 58954120, Ext-119