Bottlenecks to Flow: Optimizing Design Controls and Validation in Medical Device QMS

Medical device manufacturers face growing challenges in design controls, process validation, and regulatory compliance, often leading to inefficiencies, redundancies, and compliance risks. This two-day seminar introduces Lean Documentation and Lean Configuration principles to eliminate bottlenecks, enhance process efficiency, and improve compliance with FDA and ISO standards.

Led by Jose Mora, an industry expert in medical device quality systems, this seminar will provide practical strategies to streamline design control documentation, validation planning, risk management, CAPA, and supplier quality processes. By integrating lean principles with regulatory best practices, participants will gain a scalable, efficient, and audit-ready Quality Management System (QMS).

Whether you're struggling with complex validation documents, redundant traceability matrices, or inefficient supplier quality remediation, this seminar offers actionable solutions to simplify processes and improve compliance.

SEMINAR OBJECTIVES:

• Applying Lean Documentation & Lean Configuration Principles to optimize design control and validation.
• Design Inputs (DI), Design Outputs (DO), and Traceability Matrices (TM) – eliminating redundancy and improving efficiency.
• Process Validation Requirements & Master Validation Plans (MVPs) – ensuring compliance with FDA 21 CFR Part 820 & ISO 13485.
• Sampling Plans for Verification & Validation – leveraging statistical techniques for data-driven decision-making.
• Automated Process & Software Validation – meeting compliance standards for AI-powered and software-driven medical devices.
• Risk Management & CAPA – integrating ISO 14971 risk-based approaches into quality processes.
• Regulatory Documents (DHF, DMR, DHR) – improving document flow and ensuring seamless compliance.
• Supplier Quality Remediation – streamlining processes with lean principles and reducing audit risks.
• Failure Investigation & Root Cause Analysis – using data-driven approaches to eliminate recurring quality issues.

AGENDA

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.