🚀 Founder of BlooMed | Freelance Consultant in Design and Development for Medical Device Companies 💡 Expert in crafting strategies, planning, and budgeting for the development of medical devices; I am accompanying my clients from conception to design transfer of their medical device development. My skills include:🌐 Development strategy, schedule, and budget management; 🔬 Research and development: technical solutions, prototyping, and feasibility studies; 🏭 Industrialization and validation of manufacturing processes; 📊 Verification and validation studies of the design; 🛠️ Development procedure definition, risk management, and usability assessment; 📑 Technical documentation: Design History Files, Device Master Record, Risk Management Files, Usability Engineering Files, Submissions to authorities.

Mission & Responsibilities:- Direct report to the Board and CEO;- Hiring and development team management;- Product road map planning and budgets;- Organize and participate to board of surgeons and cadaver lab with international KOL;- Development projects: conception, industrialization/pilot manufacturing, process validations, design verification and validation, design transfer, regulatory submissions; - QMS: Design control process definition according to ISO 13485:2016, MDR & 21 CFR and Risk management process definition according to ISO 14971 & ISO 62366;- IP activitiesKey achievement:- Class III Medical devices: Full re-industrialization, process validation and design verification & validation activities completed.- PMA submissions- CE mark submissions under MDR

Mission & Responsibilities:- Project/portfolio/PMO management and product development (conception to market access, product development strategy);- Manage product development team and budget;- Created IP;- Collect directly user needs through the project teams or KOL;- Organize and participate to board of surgeon and cadaver lab with international KOL;- Conception / prototyping / proof of concept;- Process industrialization and validation / subcontractor management (industrialization / validation);- Conception verification and validation;- Pilot of the design control process;- Update Design control process to ISO 13485:2016 & MDR.Key achievement:- Class III Biodegradable CE mark;- Class IIb Sterile accessories CE mark;- Class I surgical light CE mark.- US FDA IDE Approval for vascular reconstruction sealant;- First in human clinical study approval for sutureless nerve repair device.Indications:- Sealant for vascular and cardiovascular reconstruction- Nerve reconstruction- GI Hernia mesh

Innovating development of implants and instruments for spine surgery: - Definition of input with the surgeons - Conception & prototypes- Verification and validation: mechanical tests and cadaver labs- Design transfer to the manufacturerProject management:- Project plan from technical specification to registration files- Management of a conception team (3 technical designers).- Management of registration files (CE mark & 510k)Technical support for customers (presentation of the Safe Orthopaedics products & Assistance in Operating room)Développement innovant d’implants et d’instruments pour la chirurgie du rachis:- Définition des données d’entrée avec les chirurgiens concepteurs- Conception - Suivi de la fabrication des prototypes- Vérification et validation: essais mécanique, essais en labo d'anatomie- Transfert du design au département "Industrialisation"Gestion de projet:- Planification des projets de l’élaboration des cahiers des charges aux enregistrements réglementaire (marquage CE & 510k).- Management d’une équipe de conception (3 dessinateurs, 1 stagiaire).- Gestion du dossier du marquage CE et du dosier pour obtenir le 510k (FDA)Support technique sur le terrain (assistance sur le bloc opératoire & présentation des produits de Safe Orthopaedics)

Développement de produits chirurgicaux à usage unique (sondes de nutrition, cathéters, ...)

Développement de la prothèse de hanche EXETER et de son instrumentation

Stage - Travail de recherche sur l’amélioration d’un implant osseux résorbable