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

Description:

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.

_{WHY YOU SHOULD ATTEND:}

Is your medical device QMS filled with excessive documentation, redundant data, and compliance roadblocks? Many companies struggle with maintaining traceability, process validation, and supplier quality management due to inefficient documentation practices. These bottlenecks increase costs, delay product launches, and create regulatory risks.

This seminar will help you:•   

• Eliminate inefficiencies in design control and validation using Lean Documentation principles.    
•  Enhance compliance with FDA 21 CFR 820, ISO 13485, and EU MDR without excessive paperwork.    
•  Optimize traceability matrices to seamlessly link design inputs, outputs, and verification/validation data.     
• Streamline validation strategies, reducing time spent on documentation while ensuring compliance.     
• Improve supplier quality processes, avoiding costly delays and ensuring smooth audits.

If your design, validation, or quality teams are overwhelmed with documentation chaos, this seminar will provide a fresh, structured, and efficient approach to building a compliant and lean QMS.

WHO SHOULD ATTEND:

• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Research and Development Departments
• Compliance Departments
• Production Departments
• Documentation Departments
• Operations Departments
• Medical Device Software Validation Teams
• Risk & Supplier Quality Management

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