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Faculty: José Mora


  • Date: 9/16/2022 11:00 AM - 9/16/2022 01:00 PM
  • Location: Online Event

Description

The EU MDR is a comprehensive and complex regulation that combines all aspects of placing certain types of medical devices on the EU market into one regulation. It addresses the obligations of economic operators in this role, and provides for extensive databases, clinical requirements, classifications, conformity, and many defined relationships between agencies, member states, and other directives and regulations.

This webinar deconstructs the many parts of this regulation into the elements of lean documents and lean configuration, providing an opportunity to apply these principles as a way to create and maintain flexibility as this and new harmonized standards and regulations emerge.

Why You Should Attend:

The EU MDR is only one yet very important regulation to emerge among a myriad of related, complex, and comprehensive harmonized standards, directives, and regulations.

The regulatory environment continues to both evolve and accelerate, creating the potential for massive gridlock and information overload for those who are not prepared and who plan to continue traditional methods of document control and database configuration.

This is a major opportunity to understand a new set of principles and re-tool your approach to Quality Management Systems (QMS) and document control.

Seminar Agenda:

LECTURE 1: Overview of lean documents and lean configuration

  • Genesis of chaos: How did we get here?
  • Document problems and document system problems
  • How the traditional approach generates waste
  • Product information vs. Process information
  • Theory of Lean Documents
  • From lean manufacturing to lean documents
  • Key principles of lean documents
  • Lean configuration elements

LECTURE 2: Overview of EU MDR

  • Table of Contents
  • Scope and definitions
  • Obligations of economic operators when placing devices on the market
  • Identification, traceability, and registration of devices and economic operators
  • Notified bodies
  • Classification and conformity
  • Clinical
  • Market surveillance
  • States and agencies
  • Confidentiality, data, funding
  • Final provisions
  • Annexes
  • Identifying elements of lean configuration in the EU MDR

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Compliance Departments
  • Validation Departments
  • Document Control Teams
  • Medical Device Software Engineers Departments