Freelancer profile translated to English.
Back to original languageAbout Benoit
💻 From Developer to Expert Consultant
After more than 15 years designing, developing, and managing complex software projects, I have chosen to put my experience to work for medical software publishers.
This technical background allows me today to understand and communicate with all stakeholders in a regulatory project: from development teams, Quality/Regulatory (QARA), management, auditors, and notified bodies.
🎯 My role: to secure your projects, anticipate requirements, and obtain your certifications, while maintaining the responsiveness and agility that are your strengths with your clients.
My expertise:
🔹 CE Marking (MDR 2017/745)
- Implementation of an ISO 13485 compliant QMS
- Compilation and optimization of technical documentation (IEC 62304, IEC 82304, ISO 14971, IEC 62366, etc.)
🔹 Audits & Evaluations
- Internal audit of your QMS (ISO 13485)
- Pre-evaluation of your Technical Documentation before submission to the NB
- Evaluation of your software's regulatory status (MDR & AI Act)
🔹 Regulatory Anticipation
- Preparation for the integration of the AI Act into your QMS and TD
🔹 Support for other regulations: Ségur, Sesam Vitale billing, interoperability framework
🔹 Operational Reinforcement
- Outsourcing of your testing process (Verification / Validation)
🚀 My added value: to get you certified with a pragmatic and effective approach, while preserving responsiveness to your clients' demands and enhancing their satisfaction.
📩 Ready to move towards your next certification? Let's connect.
French
Native or bilingual
Remote only
Primarily works remotely
Experience
- IndépendantRegulatory Consultant HealthApril 2019 - Today (7 years and 2 months)Île-de-France, FranceSupporting several health software publishers in their regulatory projects:- CE Marking (MDR 2017/745 and Directive 93/42)- Ségur Labeling (ANS)- LAP Certification (HAS)- Sesam Vitale BillingCE Marking Activities:• Implementation of a QMS (ISO 13485) and technical documentation (MDR 2017/745 / AI ACT)• Internal team training on various regulatory topics: requirements, verification, validation, risk analysis, ISO 13485 / ISO 14971 / IEC 62304 / IEC 82304 IEC 62366 standards...• Project management from initialization to final audit,• Assistance in setting up internal QMS tools (Jira, Confluence, Zohodesk, etc.)• Responsive regulatory support via workshops, chat, email (all profiles: technical, quality, management..),• Drafting, reviewing, and validating processes, procedures, and technical documents such as the design and development procedure, architecture specification, design dossier,• Compliance checks according to applicable standards and regulations,• Technical documentation evaluation, internal audit, regulatory qualification of health software.
- Other activities performed *
• Drafting functional documentation: user manuals, user needs..• Drafting technical specifications: architecture, security,...• Technical documentation evaluation• Regulatory support for developers and testers• Project and team management: management, marketing, clients, technical and support teams, - Tecsanté partnersTechnical Manager & Medical Software ConsultantApril 2016 - March 2019 (2 years and 11 months)Île-de-France, France
- Infosanté - LAP Certification (HAS) *
• Preparation of the Clinidoc software for certification• Coordination and participation in the audit- Infosanté - TLSi ADRi Approval / Authorization *
• Project management: preparatory acceptance testing of the eLISA software, passing the exam at the CNDA and coordination of the complete administrative procedure- Creation of a Health Insurance Card access solution on payment terminals *
• Drafting of technical and functional specifications• Monitoring and coordination of subcontractors (developers)• Validation and packaging of the solution for deployment- Initialization of a remote Health Insurance Card access solution (RAC) *
• Drafting of an architecture and security file• Conduct of the validation of the file by the GIE Sesam Vitale (RAC framework)- Design of a multi-service health terminal for health centers *
• Gathering client needs (conducting meetings, status assessment, user encounters)• Drafting technical and functional specifications (patient UI, interfaces between HIS, hardware, software architecture)• Prospecting, selection, and management of technical service providers (hardware, software)• Client support during deployment (orchestration of installations, planning, training of managers and support staff)- Cross-functional activities *
• Budget monitoring and reporting• Selection of internal tools (office, software engineering) and creation of operational processes• Participation in business development and strategic choices, - SaficardHealth Software Project ManagerJune 2012 - March 2016 (3 years and 9 months)Île-de-France, France
- TMAJ System Manager - Vit@jour *
• Completion of several Vitajour software homologations on the TMAJ 3.0 framework: EFT30, EFT930, ICT220, ICT250, IW250, Twin30/31/33 readers...- Ingenius DI Homologation *
• Participation in the homologation of Ingenius on DI 3.50 with extension to providers• Drafting and validation of the SCOR architecture file- Creation of a Health Insurance Card reader - TL 3.30 *
• Drafting and validation of the architecture file• Leading hardware and software development of the prototype• Initiation of testing campaigns with the GIE Sesam Vitale- Cross-functional activities *
• Review and optimization of system architecture• Technological watch and competitive analysis• Production of documents (architecture, operation, user manual)• Implementation of quality procedures (delivery, sales administration)• Management of the development and testing team• Conducting inter-departmental meetings• Training of technical support and Level 3 assistance• Assistance to the pre-sales department (tenders, technical meetings),
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Education
- Medical Device CybersecurityMD1012021Cybersécurité des Dispositifs Médicaux
- ISO 13485:2016 Clause by ClauseBSI Training Academy2021ISO 13485:2016 Chapitre par chapitre
Skill set (7)
Categories
- Other