Move beyond document-centric compliance — learn how to structure device records as an interconnected system of relationships that remains coherent, traceable, and defensible under FDA inspection scrutiny.
Includes live access & recording
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. Information becomes duplicated, fragmented, difficult to maintain, and increasingly vulnerable to inconsistency as products evolve.
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 — using real-world examples to show how seemingly isolated changes propagate throughout a quality system.
Many organizations approach inspection readiness by concentrating on documents — reviewing procedures, updating records, reconciling training files, and verifying that required forms have been completed. While important, these activities often overlook the challenge that emerges when an investigator begins to examine how the quality system actually works.
An investigator may begin with a seemingly straightforward question about a product requirement, a design change, a manufacturing process, or a risk control. Very quickly, the discussion moves beyond individual documents and into the relationships among them — exposing structural weaknesses that remain hidden during routine operations.
This webinar examines inspection readiness from a different perspective. Rather than focusing solely on documents, it focuses on the relationships that give those documents meaning — providing practical methods for improving traceability, strengthening consistency, and building confidence that records remain synchronized as products and organizations evolve.
Four relationship-centric focus areas that will transform how your organization structures, maintains, and defends device records during FDA inspections.
Understand the Lean Documents and Lean Configuration methodology — a relationship-centric approach that replaces fragmented document silos with a coherent, traceable system of interconnected device records.
Learn how DDF, MDF, DHF, DMR, DHR, Risk Management Files, and validation records relate to one another — and how to map those relationships so they remain visible, consistent, and inspection-ready.
Discover how relationship-based thinking improves change impact analysis — enabling organizations to identify downstream effects before they create inconsistencies across requirements, risks, controls, and evidence.
Build inspection readiness that goes beyond document possession — demonstrating that records are coherent, synchronized, and internally consistent in response to QMSR expectations and investigator scrutiny.
Ten focused topics covering the full scope of QMSR device records, relationship integrity, and relationship-centric inspection readiness.
Medical device professionals across design, quality, regulatory, and manufacturing functions responsible for device records, inspection readiness, and QMSR compliance.
Research and Development
Quality Assurance
Design Assurance
Regulatory Affairs
Manufacturing Engineering
Operations
Supplier Quality
Document Control
Quality Systems
The Quality Management System Regulation (QMSR) and the increasing emphasis on inspection readiness have forced medical device manufacturers to reexamine the structure and integrity of their device records. Many organizations possess the required documents and records, yet struggle to explain how those records relate to one another. During audits and inspections, this often manifests itself as delays, inconsistent answers, traceability gaps, conflicting information, and excessive dependence upon tribal knowledge.
Historically, organizations focused on document creation and document control. Today, regulators and auditors increasingly expect organizations to demonstrate the relationships between intended use, requirements, risk controls, design outputs, manufacturing controls, verification evidence, validation evidence, and released product configurations.
As products become more complex and organizations increasingly rely upon outsourced design, manufacturing, testing, software development, and specialized suppliers, maintaining relationship integrity across records becomes increasingly difficult. This webinar introduces a Lean Documents and Lean Configuration perspective on Device Records and explains how organizations can move beyond document-centric thinking toward relationship-centric inspection readiness — reducing complexity, improving traceability, and strengthening confidence that records remain synchronized throughout the entire product lifecycle.
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.
Join José Mora for this 90-minute deep-dive into QMSR device records, relationship integrity, and inspection readiness that goes beyond documents.