ISO 13485:2016 using Lean Principles – Don’t let the New Requirements Surprise You

ISO 13485:2016 using Lean Principles - Don't let the New Requirements Surprise You

Medical device designers and manufacturers are required to follow ISO 13485, and will be expected to implement the 2016 revision changes. There is an additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

It would be a major oversight to think of these changes as anything but a profound game-changer in terms of expectations and requirements.

Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.

This webinar is an overview of the coming changes and their implications, using a new approach yet is based upon solid principles and proven practices.

Viewing this in the context of Lean Documents and Lean Configuration will provide clarity prior to embarking upon these changes.

Areas Covered in the Session :
Brief introduction to Lean Documents and Lean Configuration
ISO 13485:2016 versus ISO 13485:2003
Overview of ISO 13485:2016
Systemic Requirements
Management Requirements
Resource Requirements
Realization Requirements
Remedial Requirements
Changes to ISO 13485:2016
Regulatory requirements
Risk-based approach
Medical device file
Record keeping
Product realization
User training
Design and development
Purchasing
Process validation
Servicing
Complaints
Delivery of nonconforming product
Improvement
How to apply the principles of lean documents and lean configuration provide a unique approach to creating continuity between the various elements of the Quality Management System (QMS) while avoiding unnecessary complexity and redundancy.
Bringing it all together

Who Will Benefit:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Research & Development
Design Assurance
Quality Assurance
Operations
Document Control
Manufacturing Engineering

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.

Refund Policy

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance