Traceability is not a bigger matrix — it is an observable property of a trustworthy product configuration. Learn to maintain configured information and its relationships so traceability is produced, not reconstructed, as products evolve.
Includes live access & recording
In the context of modern medical device quality systems and the FDA's QMSR alignment with ISO 13485:2016, maintaining traceability between user requirements, risk controls, and verification evidence is less about producing a larger traceability matrix and more about maintaining a trustworthy product configuration throughout the lifecycle.
Traceability is an observable property of that maintained configuration: the ability to determine what configured information objects are connected, why the relationships exist, under which approved state and applicability or effectivity they are valid, and what objective evidence supports them.
This topic is especially relevant in organizations transitioning from document-centric quality systems toward configuration-centric, data-centric quality systems. In such systems, documents are controlled views, packages, or outputs assembled from configured information — they should not become isolated containers in which critical relationships or configuration state exist only as repeated text.
Many medical device companies maintain separate documents for user requirements, risk management, verification testing, and design history. These documents are often connected manually. As products change, links between them can become outdated, broken, or configuration-wrong, making it difficult to determine how a requirement was addressed, how a risk was controlled, what design output implemented the control, or what evidence proves compliance for the applicable product configuration.
A common assumption is that a traceability matrix equals traceability. It does not. A matrix is a view or report of a configuration at a point in time. The source of truth is the controlled configuration state: the maintained information objects, their defined relationships, their approved states, their applicability or effectivity, and the changes and evidence associated with them.
This webinar explores how to maintain configured information and its relationships rather than relying on documents alone — so change impact is exposed before approval rather than reconstructed during an inspection.
Four shifts in thinking that move an organization from document-centric, through relationship-centric, to a configuration-centric quality system.
Understand the controlled relationships among user need, design input, hazardous situation, risk control measure, design output, verification method, verification result, residual risk, approved change, and applicable product configuration.
A relationship can exist and still be wrong — pointing to the wrong revision, an obsolete method, evidence generated against a different configuration, or an object outside its applicability or effectivity. Learn to tell the difference.
A change to one configured object can affect risk analysis, risk controls, design outputs, verification methods, evidence, residual-risk conclusions, and the configurations they apply to. Expose affected objects before change approval.
When objects, relationships, states, applicability, changes, and evidence are maintained as a coherent configuration, a traceability matrix, risk-management report, or inspection response becomes a controlled view of the same state.
Attendees will leave able to treat traceability as a product of a correctly maintained configuration rather than something reconstructed through document updates.
Identify gaps between requirements, risks, design outputs, and testing.
Distinguish connected relationships from correct configuration relationships.
Perform change impact assessments more effectively.
Reduce manual updates across multiple documents.
Achieve inspection readiness by demonstrating the approved configuration and the evidence supporting it.
Shift from a document-centric mindset through relationship-centric thinking to a configuration-centric quality system.
Twelve focused topics covering why traceability fails in document-centric systems and how a maintained configuration produces it instead.
Teams across engineering, quality, regulatory, and configuration management responsible for requirements, risk, verification evidence, and change control.
Manufacturing Departments
Engineering Departments
Quality Assurance Departments
Operations Departments
Systems Engineering Teams
Design Engineering Teams
Design Assurance Teams
Risk Management Teams
Verification & Validation Teams
Software Quality Departments
Regulatory Affairs Departments
Configuration Management Teams
Document & Information Management
Engineering Change Control Teams
The maintained product configuration includes controlled relationships among user need, user requirement or design input, hazardous situation or identified risk, risk control measure, design output implementing the control, verification method, verification result and objective evidence, residual risk evaluation, approved change and affected configuration objects, and the applicable or effective product configuration.
Attendees will see traceability not merely as connected information or linked documents, but as an observable property of a correctly maintained configuration. A relationship can exist and still be wrong if it points to the wrong revision, an obsolete method, evidence generated against a different configuration, or an object outside its applicability or effectivity. Practitioners begin asking: what user need does this requirement support? What risk does this control address? Which approved design output implements the requirement or risk control? What approved verification method demonstrates implementation or effectiveness, and where is the resulting objective evidence? For which product configuration, revision, applicability, or effectivity is this relationship valid?
A configuration-centric quality system requires practical operational controls such as defined information-object types, defined relationship types, stable identifiers, controlled object and relationship status, revision state, applicability or effectivity, and approved change. When configured information objects, relationships, states, applicability or effectivity, changes, and objective evidence are maintained as a coherent configuration, documentation becomes easier to generate and maintain, change impact becomes easier to assess, and compliance evidence becomes easier to demonstrate — with a traceability matrix, risk-management report, verification summary, or inspection response treated as a controlled view of the same configured state rather than a competing source of truth.
José Ignacio Mora is a seasoned Principal Consultant specializing in Manufacturing Engineering and Quality Systems, with over 30 years of experience in the medical-device and life-sciences industries. His expertise lies in manufacturing, process development, tooling, and quality systems. Before joining Atzari Consulting as a consulting partner, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics.
José has an impressive track record of leading the successful launch of manufacturing at a startup urology products company and creating a world-class medical device manufacturing operation using JIT, kanban systems, visual workplace, and lean manufacturing practices. His expertise extends to surgical instruments; PTA and PTCA dilatation and guiding catheters; plastic surgery implants and tissue expanders; urology implants and devices; delivery systems for brachytherapy; orthopedic implants and instruments; and vascular surgery grafts and textiles.
José has received training in, and has decades of hands-on experience applying, world-class methodologies, including Kepner-Tregoe, Taguchi techniques, the Theory of Constraints, Lean Manufacturing, 5S (Visual Workplace), process validation to Global Harmonization Task Force (GHTF) guidance and standards, and similar approaches.
Join José Mora for this 90-minute session on maintaining traceability between user requirements, risk controls, and verification evidence through a trustworthy product configuration.