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Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD1885


  • Date: 8/10/2023 11:00 AM - 8/10/2023 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

Description

The ECO process is critical for ensuring the safety and effectiveness of medical devices. It helps to identify potential issues before they become problems and ensures that any changes made to the device are well-documented, approved, and validated.

Overall, the ECO process is a collaborative effort involving multiple functional areas to ensure that the change is thoroughly evaluated, implemented correctly, and compliant with regulatory requirements. Each functional area plays a critical role in the process to ensure that the device is safe and effective for patient use.

Why Should You Attend:

Many companies struggle to manage these changes due to the many documents and elements involved as well as the role of each function.  A typical symptom is an enormous checklist that while intended to ensure compliance ends up becoming an obstacle to changes.

Given the never-ending volume of information, the lean documents and lean configuration approach provides a single source of truth and streamlined data set to help create and manage the ECO process.

AREAS COVERED IN THE SESSION:

  • Introduction to principles of lean documents and lean configuration
  • The ECO process flow
  • Importance and expectations
  • Typical steps in generating an ECO
  • Role of each functional area in the process
  • Site-specific considerations
  • Summary and Conclusion

WHO SHOULD ATTEND:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Risk Management Professionals

Course Director: José Mora

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 José’’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.