Marine Di Maria

Building on my Usability experience in the medical device field, I offer my consulting services to help you build or improve your usability procedures for the European and American (FDA) markets:

- Product design analysis,

- Design improvement proposals,

- Creation/improvement of usability documentation (Usability Engineering File and HFE report), including the associated risk process,

- Implementation of a Usability strategy,

- Organization of formative and summative evaluations, in Europe and the United States,

- Drafting of test protocols and reports,

- Analysis of results (root causes and risks analysis),

- Connection with expert companies in the field (comparative studies).

• Implementation of the Usability procedure according to IEC62366 standards and the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices.

• Implementation of test strategies during development (formative) and for validation (summative).

• Organization of tests, analysis of results, understanding of problems, risk assessment, and proposal of improvements.

• Drafting of Usability Engineering Files (CE marking) and Human Factors Engineering reports (510(k)).

• Teamwork with design, systems, software, and regulatory affairs teams.

• Coordination and management of product validation tests (usability) in Europe and abroad (United Kingdom and United States) according to EN62366 standards (2007 and 2015) and the FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (2016) on several Fresenius product lines (infusion pump medical devices).

-> Test strategies (planning, organization, and logistics),

-> Drafting of test protocols,

-> Conducting tests,

-> Analysis of results, understanding of problems (design thinking and root causes), risk assessment, and proposal of improvements (problem-solving),

-> Drafting of test reports,

-> Presentation of results to project teams.

• Coordination of the Product Validation Tests team (3 engineers).

• Knowledge of European and FDA standards related to medical devices: participation in the drafting of FDA files (510k) and several CE markings.

• Close collaboration with multidisciplinary teams: R&D, risk management, marketing, regulatory affairs, quality, verification, and validation.

• Management of subcontractors (prospecting and collaboration).

• Drafting of a usability instruction procedure as part of the quality procedure for the European and North American markets. Training teams on this new procedure.