Faculty: José Mora
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.
LECTURE 1: Overview of lean documents and lean configuration
LECTURE 2: Overview of EU MDR
Who Should Attend: