Length: 2 Days
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Introduction to Medical Device Regulation (MDR) Compliance Training by Tonex

This course offers an introduction to the regulatory landscape for medical devices, focusing on compliance with the European Medical Device Regulation (MDR). Students will learn about the requirements, processes, and best practices for ensuring medical device safety and efficacy.

Learning Objectives

  • Understand the MDR framework and its importance.
  • Learn about the classification and conformity assessment of medical devices.
  • Explore the requirements for clinical evaluation and investigation.
  • Analyze the post-market surveillance and vigilance processes.
  • Study the roles and responsibilities of economic operators.
  • Develop strategies for achieving and maintaining MDR compliance.

Audience

  • Medical device professionals
  • Regulatory affairs specialists
  • Quality assurance professionals
  • Healthcare professionals
  • Academics in biomedical engineering and healthcare management

Program Modules

Module 1: Introduction to MDR

  • Overview of MDR and its significance
  • Key changes from previous regulations
  • Scope and applicability
  • MDR structure and annexes
  • Timeline for implementation
  • Case studies on MDR introduction

Module 2: Classification and Conformity Assessment

  • Device classification criteria
  • Conformity assessment procedures
  • Role of notified bodies
  • Technical documentation requirements
  • Clinical evidence and evaluation
  • Case studies on conformity assessment

Module 3: Clinical Evaluation and Investigation

  • Clinical evaluation requirements
  • Conducting clinical investigations
  • Ethical and legal considerations
  • Data collection and analysis
  • Reporting and documentation
  • Case studies on clinical evaluation

Module 4: Post-Market Surveillance and Vigilance

  • Post-market surveillance system
  • Vigilance reporting requirements
  • Risk management and mitigation
  • Incident investigation and corrective actions
  • Continuous improvement
  • Case studies on post-market activities

Module 5: Roles and Responsibilities of Economic Operators

  • Manufacturers’ obligations
  • Authorized representatives
  • Importers and distributors
  • UDI system and labeling requirements
  • Quality management systems
  • Case studies on roles and responsibilities

Module 6: Achieving and Maintaining Compliance

  • Developing a compliance strategy
  • Training and awareness programs
  • Audits and inspections
  • Documentation and record-keeping
  • Regulatory updates and adaptations
  • Group exercise: Crafting a compliance plan

 

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