Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration

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.

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Last Recorded Date: Apr-2024

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Why Should You 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 (QMSs) and document control.

Areas Covered in the Webinar:
  • 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 Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Research and Development Departments
  • Compliance Departments
  • Production Departments
  • Documentation Departments
  • Operations Departments
  • Medical Device Software Engineers
  • Medical Device Software Validation Departments
  • Medical Device Software Compliance Engineers
  • Document Control Teams
Instructor Profile:
Jose Mora Jose Mora

Principal Consultant, Atzari Enterprises

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems.

Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies. During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment.

Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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