Skip to content

Awareness Program on EU Medical Device Regulations (EUMDR)

Course Feature

This course is designed to meet the requirement of competent auditors referred in ISO 19011. The course includes class room sessions coupled with syndicate group exercises to enhance delegate participation to achieve learning objectives. Medical Devices - Quality Management System that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support).

About Training Program

To enable delegates understand Key concepts in OVERVIEW OF EU MDR 2017

9:00 AM to 6:00 PM

Generally anyone involved in Medical Devices Industry but specifically:

  • Quality executives/managers
  • R& D Personnel
  • Regulatory Affairs personnel
  • Management representatives
  • QMS Consultants
  • MD Importers
  • MD Software developers/validators
  • Personnel wishing to attend higher level courses such as Lead Auditor courses.
     

  • Introduction to Medical Device
  • What’s New - Introduction to EU MDR
  • Main Articles and Annexes
  • Scope
  • New or Modified Definition
  • Clinical Evaluation consultation and Mechanism of Scrutiny
  • Summary Of Safety and Clinical Performance
  • General Safety and Performance
  • Enforcements Dated – Interpretation of Article 120 and 123
  • Implementing acts 
     

  • Overview of ISO 62366 and its significance in medical device development
  • User-Centered Design Principles
  • User Research and User Needs
  • Use Specification Development
  • Risk Management and Usability
  • Usability Evaluation Methods
  • Usability Validation
  • Documentation and Compliance
     

Certificate of successful completion shall be issued to all the delegates who attend entire duration of the course and pass the online exam.

8 Hours including a break of 1 hour for both days

In case of change or cancellation of any scheduled program from TUV India Pvt. Ltd, fees paid for participation will be initiated for refund to the respective participant / client account within 21 days once required information is provided by participant / client.