Freelancer profile translated to English.
Back to original languageAbout Pascal
Independent expert in the field of medical devices, particularly software and electro-medical devices, I assist you in all your Quality and Regulatory Affairs processes and projects in Europe and the USA:
Technical files for CE marking and 510(k) submissions
Implementation of QMS 13485:2016 or 21 CFR part 820
Risk Management (ISO 14971)
Usability Engineering (ISO 62366)
Cybersecurity (ISO 27005/AAMI TIR 57)
Software Lifecycle (ISO 62304)
Internal Audits (ISO 19011)
With my technical background, I am also able to carry out certain product development activities, including:
Program or project management
Value analysis
Product definition and requirements management
Proof of concept, demonstrators, and feasibility studies
Software architecture and development
Verification & Validation,
French
Native or bilingual
English
Fluent
German
Conversational
Can work on-site
Annecy (up to 50km)
Experience
- MDSW ConseilFreelanceAugust 2019 - Today (6 years and 10 months)Annecy🏥 Medical Devices — MDR / IVDR / FDA
- Establishment and maintenance of QMS effectiveness
- Technical file preparation
- Internal audits and preparation for notified body audits
- ISO 13485 · 14971 · 62304 · 62366-1 · 82304-1 · 81001-5-1 · PMS · 510k
⚙️ SaMD & DTx Technical Direction- Medical software program/project direction and management
- R&D supervision
- Software architecture
- Product risk management according to ISO 14971
- Product roadmap
- Feasibility studies
🤖 AI in Health — AI Act / ISO 42001- AI Act classification
- Establishment and maintenance of AI Management System (integrated with 13485 as needed)
- AIaMD · IMDRF AI/ML · FDA AI Action Plan · HL7 FHIR Interoperability compliance
🩺 Health & Digital Therapeutics — DTx / mHealth- DTx strategy and compliance · Good DTx Practices · HAS · DIGA · COCIR mHealth
🎓 Tailored TrainingMDR · IVDR · ISO 13485 · 14971 · 62304 · 62366-1 · 82304-1 · 81001-5-1 · AI Act · ISO 42001 - PIXEE MEDICALHead of R&DDecember 2017 - July 2019 (1 year and 7 months)Annecy
- Strategic definition of the company's product line: "Mixed and Augmented Reality Autonomous Surgical Navigation Solutions"
- Management of the product line's projects, the R&D team, and Quality & Regulatory (10 employees).
- Implementation of R&D activities and guarantor of the tools and methodologies used.
- Technical referent for technological projects.
- Regular contributor to the company's QMS. Pilot of several processes (R&D, HR). Participation in the creation of the company's QMS (13485). Implementation of specific requirements for software development (ISO82304-1, EN62304, EN62366, etc.) and risk control (EN ISO 4971). Active participation in the creation of technical file elements for CE marking, including leading risk management activities.
- Pre-clinical and clinical validation.
- TuralProject ManagerMarch 2012 - December 2017 (5 years and 9 months)Marignier - France▪Product definition and marketing for all "Smart tools" for orthopedic surgery developed by the company (Computer assisted surgery system, Quantify Yourself projects, preoperative planning software, ...)▪Management of all software development projects, under Quality Assurance, going to CE marking: stakeholder reporting, team management, animation, technical expertise, regulatory documentation, technology and standards watch, subcontractors identification …▪Guarantor of software development tools and methodologies used in the company.▪Contributor to the QMS of the company.▪Preclinical and clinical validation
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Education
- Master of Science (MSc)Université Paul Cézanne (Aix-Marseille III)2002
- Master of Science (MSc)Université de la Méditerranée (Aix-Marseille II)2001
Certifications
- Internal Auditor 13485BSI
Skill set
Categories
- Other