LIVE WEBINAR
QMSR Device Records
Structuring DDF, MDF and Related Relationships for Inspection Readiness
- June 23, 2026
- 11 AM Eastern Time US
- 3 PM GMT
- 90 Minutes
- Streaming Available
- 90 Minutes
- Certificate of Completion
Designed for organizations responsible for creating, maintaining, reviewing, or relying on interconnected product, quality, risk, and manufacturing records.
ABOUT THE COURSE
Organizations transitioning to QMSR must increasingly explain how product requirements, risks, evidence, changes, and released configurations remain connected across evolving device records. This session organizes device records around relationship integrity, helping teams maintain traceability, consistency, and change visibility throughout the product lifecycle.
The session introduces Lean Documents and Lean Configuration concepts before examining how major device records interact across development, manufacturing, risk management, validation, and change activities. Practical examples demonstrate how relationship mapping improves traceability, supports change impact evaluation, and strengthens inspection readiness beyond document control alone.
Key Areas Covered
- Understanding DDF, MDF, and related device records
- Mapping relationships across requirements, risks, and evidence
- Configuration management versus document management
- Traceability across design, manufacturing, and quality activities
- Design changes and change impact assessment
- Maintaining lifecycle consistency across interconnected records
- Inspection readiness through relationship integrity
José Mora
José Ignacio Mora developed the Lean Documents and Lean Configuration methodology specifically to address the challenges of traceability, configuration management, and record relationships within medical device quality systems. Drawing on more than thirty years in design controls, manufacturing engineering, validation, quality systems, and regulatory compliance, he brings direct experience connecting product lifecycle information into coherent, inspection-ready systems.
What Happens After You Reserve Your Seat
Your registration is managed by our events team to ensure a coordinated and seamless experience.
- A confirmation email outlines onboarding details and next steps
- Access credentials are shared in advance so you are prepared before the session
- Handouts (where applicable) are provided ahead of time
- The training is delivered live via Webex with interactive participation and Q&A
- Certificates of completion are issued following the session
- For live + recording access, post-session availability is provided through TalkFDA
- Event support remains available for any access or logistics assistance
Access is provided in a structured and professionally supported format.
- A confirmation email outlines onboarding and next steps
- The complete session recording is delivered through TalkFDA
- Access is granted shortly after purchase so you can begin without delay
- Recording includes the full presentation and instructor-led discussion
- Certificates of completion are issued upon course completion
- Support remains available for any technical or access assistance
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