QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness

A practical session on structuring device record relationships across design, risk, manufacturing, validation, change impact, and inspection evidence under QMSR expectations.

EXCLUSIVE: Get your team to

attend for just $ 390.

Individual registrations available too.

COURSE OVERVIEW & STRUCTURE

Device records fail when relationships are unclear.

Device teams must show how requirements, risks, controls, evidence, and released configurations remain connected across product lifecycle records. This session structures DDF, MDF, risk, validation, manufacturing, and quality records through relationship mapping, configuration thinking, and change impact analysis.

The session moves from document-centric recordkeeping to relationship-based inspection readiness. It examines how device records connect across design, risk, manufacturing, validation, supplier, and quality activities, with practical emphasis on traceability, configuration management, change impact, and lifecycle consistency.

WHAT YOU’LL LEARN

Effectively Mapping device record relationships under QMSR

Lean Documents and Lean Configuration principles
QMSR device record structure
DDF, MDF, and related record relationships
Traceability across requirements, risks, and evidence
Configuration management versus document management
Design change and impact analysis
Consistency across lifecycle records
Inspection readiness through relationship integrity

WHO SHOULD ATTEND

Designed for professionals responsible for creating, maintaining, reviewing, or explaining device records across product lifecycle activities.

Quality Assurance

Regulatory Affairs

Research and Development

Manufacturing

Engineering

Validation

Operations

Supplier Quality

Design Assurance

Document Control

FACULTY

José Mora

José Ignacio Mora brings more than three decades of medical device experience across design controls, manufacturing engineering, quality systems, process validation, supplier management, technology transfer, and compliance. As creator of Lean Documents and Lean Configuration, he is specifically suited to address relationship-based device record structure, traceability, configuration integrity, and inspection readiness under QMSR.

AFTER YOU REGISTER

Everything related to your course lives in one place.

MD1382

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness

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