QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness
Learn how to structure QMSR Device Records using Lean Documents and Lean Configuration principles to achieve true inspection readiness through relationship integrity, not just document control.
Instructor
José Mora
Medical Device Quality Systems & Configuration Management Consultant
What You'll Learn
About the event
About this event
Medical device organizations generate enormous amounts of information throughout the product lifecycle. Intended use statements, user needs, design requirements, risk analyses, specifications, test protocols, test reports, manufacturing procedures, validation records, complaint records, CAPAs, and change records all contribute to the overall body of evidence supporting a medical device.
Unfortunately, many quality systems evolved around documents rather than relationships. As a result, organizations often maintain hundreds or thousands of controlled documents without a clear understanding of how information flows between them.
This webinar introduces the principles of Lean Documents and Lean Configuration as a framework for understanding Device Records within a larger system of relationships. Participants will examine how Design Development Files, Medical Device Files, Risk Management Files, Design History Files, Device Master Records, Device History Records, validation records, and related quality system records interact throughout the lifecycle of a product.
Special emphasis will be placed on understanding traceability, change impact analysis, configuration management, and relationship integrity. Real-world examples will be used to illustrate how seemingly isolated changes can propagate throughout a quality system and how relationship-based approaches can improve both operational effectiveness and inspection readiness.
Code: MD1382
Curriculum
Requirements
- Working in medical device design, development, quality, or regulatory functions
- Familiarity with QMSR, 21 CFR Part 820, or ISO 13485
- Applicable to established manufacturers and rapidly growing organizations
Who Should Attend
Research and Development, Quality Assurance, Design Assurance, Regulatory Affairs, Manufacturing Engineering, Operations, Supplier Quality, Document Control, and Quality Systems professionals in the medical device industry.
Areas Covered
Meet Your Instructor
José Mora
Medical Device Quality Systems & Configuration Management Consultant
José Ignacio Mora is a Principal Consultant specializing in Manufacturing Engineering, Quality Systems, Design Controls, and Configuration Management within the medical device industry. For more than three decades he has worked across product development, manufacturing, quality systems, process validation, supplier management, technology transfer, and regulatory compliance. His experience includes leadership positions at Boston Scientific, Stryker Orthopedics, Cordis Corporation, and multiple start-up medical device organizations. José is the creator of the Lean Documents and Lean Configuration methodology, a relationship-centric approach to managing quality system information. His work focuses on improving traceability, reducing information fragmentation, strengthening inspection readiness, and creating more effective connections between requirements, risks, verification activities, validation activities, and released product configurations. Drawing from practical experience in design controls, process validation, manufacturing systems, quality systems remediation, and organizational transformation, José provides a unique perspective on how organizations can achieve compliance while simultaneously reducing complexity and improving operational effectiveness.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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