Deconstructing EU MDR with Principles of Lean Documents and Lean Configuration
Instructor:
Jose Mora
Product ID: 706959
Training Level: Intermediate
- Duration: 120 Min
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 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
Jose Mora
Principal Consultant, Atzari Enterprises
José 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. José 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. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José managed the Maintenance and Facilities Department, taking that operation to a level rated as “tops” by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches.
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