Loïc M.

Generalist engineer, I specialize in project management, systems engineering, and quality, which I practice through innovation projects in the medical device industry. Today, as an independent consultant and PMP certified, I put my operational management and product development skills at the service of clients. I adapt to different environments and strive to bring efficiency and simplicity to achieve the objectives defined together.

Example of services:

PROJECT MANAGEMENT/PMO:

- Consolidation of client needs

- Initiation: "charter", stakeholders, definition of the life cycle, assumptions, costing...

- Planning: WBS, activities, phases, quality, risks, costs... and definition of baselines to evaluate performance

- Execution: risk management, communication management, issues log, remaining work diagram, earned value analysis, performance evaluation and review, change management...

- Control: risks, scope, schedule, and cost...

- Project closure: handover, lessons learned...

- Continuous improvement (processes, organization, tools)

Commonly used tools: MS Project, Visio

SYSTEMS & QUALITY ENG. (MD certification) :

- Writing user specifications

- Writing system specifications

- Review of the product development cycle ("design control")

- Performing gap analysis against a normative framework

- Risk management (e.g., PHA, DFMEA)

- Document writing (DHF)

- Writing qualification protocols (FAT/SAT)

- Regulatory analysis (classification, performance evaluation and applied standards, definition of use steps and associated risks...)

Standards and frameworks used: EU Regulation 2017/745,

ISO 13485, ISO 14971, ISO 11608, IEC 62304, IEC 60601, IEC 62366

Clients:

- Medex (2024-2025), Becton Dickinson (2023), Church & Dwight (2022), Nemera (2022), BD (2021)