Strengthen your ability to assess product changes across connected technical documentation — identifying where design modifications affect risk, clinical conclusions, verification evidence, and the regulatory record before inconsistencies become embedded.
Includes live access & recording
EU MDR technical documentation must remain internally consistent as a medical device changes through its lifecycle. A modification to design, materials, software, manufacturing, suppliers, intended use, or performance can affect risk controls, verification and validation evidence, clinical conclusions, labeling, and other records that support the approved device configuration.
When these elements are maintained separately, individually controlled documents can still describe different product states. A configuration-centered approach treats technical documentation as connected information rather than isolated files.
This course focuses on identifying relationships among design information, risk controls, clinical evidence, verification evidence, and approved changes so that impact can be assessed before records drift apart. It addresses how applicability, effectivity, revision state, and objective evidence help determine whether existing conclusions remain valid after change — while supporting coherent technical documentation for EU MDR conformity assessment, Notified Body review, and ongoing regulatory oversight.
Product changes can create regulatory exposure when affected records are identified by document name rather than by their relationship to the changed product configuration. Develop a more disciplined way to follow change impact across design information, risk controls, clinical evidence, verification and validation, labeling, manufacturing information, and supporting regulatory records.
A current document does not guarantee that its evidence applies to the current device configuration. Strengthen the ability to question revision state, applicability, effectivity, and supporting evidence so that risk conclusions, clinical support, verification results, and design records remain aligned when technical documentation is reviewed.
Four configuration-centered focus areas that keep risk, clinical, and design records aligned as a device evolves under EU MDR.
See design requirements, risk controls, clinical evidence, and verification and validation records as a connected system built around the product configuration — not as isolated, individually controlled files.
Trace how changes to materials, software, suppliers, manufacturing processes, design characteristics, intended use, and performance ripple through the technical documentation.
Use applicability, effectivity, revision state, and objective evidence to decide whether risk, clinical, and verification conclusions still apply after an approved product or process change.
Maintain coherent technical documentation for EU MDR conformity assessment, Notified Body review, and ongoing regulatory oversight — assessed before approval rather than reconstructed later.
Eight focused topics covering configuration-centered change assessment across EU MDR technical documentation.
Professionals responsible for EU MDR technical documentation, product change control, and the risk, clinical, design, and verification records that support the approved device configuration.
Regulatory Affairs Professionals
Quality Assurance & Quality Engineering
Design Assurance & Design Engineering
Risk Management Professionals
Clinical Affairs & Clinical Evaluation
Verification & Validation Professionals
Systems & Software Engineering
Manufacturing & Process Engineering
Configuration & Change Management
Document & Information Management
Compliance & Internal Audit
Managers for MDR Documentation & Product Change Control
Under the EU Medical Device Regulation, technical documentation is the central body of evidence demonstrating that a device meets the general safety and performance requirements. That documentation is not a single file but a set of interdependent records — design information, risk management, clinical evaluation, verification and validation, labeling, and manufacturing information — that together describe one approved device configuration.
Devices change. Materials are substituted, software is updated, suppliers and manufacturing sites are transferred, design characteristics are refined, and intended use or performance claims are adjusted. Each change has the potential to invalidate a risk control, a clinical conclusion, or a piece of verification evidence that was generated against a previous configuration. When affected records are identified by document name rather than by their relationship to the changed configuration, inconsistencies can become embedded before anyone notices.
This session presents a configuration-centered way of working: treating technical documentation as connected information, using applicability, effectivity, revision state, and objective evidence to test whether existing conclusions still hold, and assessing change impact before approval rather than reconstructing it during Notified Body review or regulatory oversight. The result is technical documentation that stays coherent, traceable, and defensible throughout the device lifecycle.
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 keeping risk, clinical, and design records consistent across EU MDR technical documentation as products change.