EU MDR Technical Documentation: Keeping Risk, Clinical and Design Records Consistent Through Product Changes

This course strengthens the ability to assess product changes across connected technical documentation, helping teams identify where design modifications affect risk, clinical conclusions, verification evidence, and the regulatory record before inconsistencies become embedded.

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.

_{WHY YOU SHOULD ATTEND:}

Follow Change Impact Across the Technical Documentation

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.

Determine Whether Existing Evidence Still Applies

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.

_{AREAS COVERED:}

• Relationships among design requirements, risk controls, clinical evidence, verification and validation records
• Product configuration as the basis for maintaining consistent EU MDR technical documentation
• Change impact across materials, software, suppliers, manufacturing processes, design characteristics, intended use, and performance
• Applicability and effectivity of existing evidence after an approved product or process change
• Identifying missing, stale, conflicting, or configuration-wrong relationships across controlled information
• Alignment of risk conclusions, clinical support, design records, labeling, and verification evidence
• Configuration-centered change assessment before approval rather than document-by-document reconstruction
• Technical documentation consistency for EU MDR conformity assessment, Notified Body review, and regulatory oversight

_{WHO SHOULD ATTEND:}

• Regulatory Affairs professionals
• Quality Assurance and Quality Engineering
• Design Assurance and Design Engineering
• Risk Management professionals
• Clinical Affairs and Clinical Evaluation personnel
• Verification and Validation professionals
• Systems and Software Engineering
• Manufacturing and Process Engineering
• Configuration and Change Management
• Document and Information Management
• Compliance and Internal Audit professionals
• Managers responsible for EU MDR technical documentation and product change control

Course Director: JOSE MORA

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.