Freelancer profile translated to English.
Back to original languageAbout Laureen
💼 Consultant & Trainer in Medical Software Devices
🚀 Save time, secure your compliance, and accelerate your market access.
Let's work together to make your medical (or non-medical) software a regulatory and commercial success!
🎓 Professional Training: From Theory to Practice
I offer customized training for companies looking to strengthen their skills in developing software compliant with medical standards.
Each training session combines theory with direct application to your projects.
Main Topics:
- IEC 62304 – Medical Device Software Lifecycle
- ISO 14971 – Risk Management
- IEC 62366 – Usability Engineering (UX)
- IEC 82304 – Non-embedded Health Software
👉 These trainings enable your teams (dev, QA/RA, product) to understand regulatory requirements and apply them concretely to their projects.
🧭 Consulting and Support
💡 Expert Consultant in Medical Device Software – From Idea to Market Launch
I support startups and SMEs in the design, development, and market launch of medical device software (SaMD), while ensuring their compliance with key standards (ISO 13485, IEC 62304, MDR, etc.).
Services offered:
- Software functional breakdown
- Software architecture definition & technical documentation
- Regulatory strategy and software classification
- CE marking compliance (MDR 2017/745)
- Implementation and optimization of Quality Management Systems (ISO 13485)
- Internal audit and certification support
🔧 Methods & Tools
Agile, collaborative, and tool-based approach, adapted to regulated environments:
Notion • Confluence • Jira • Azure DevOps • Git/GitLab • Microsoft 365 • Google Workspace • Asana
French
Native or bilingual
English
Fluent
Can work on-site
Paris (up to 15km)
Experience
- SateliaProject Manager Medical DevicesHEALTH AND WELLNESSFebruary 2025 - Today (1 year and 4 months)Bordeaux, France
- Full management of medical device software projects (class I and IIa), from requirements definition to CE marking.
- Coordination of teams (dev, quality, clinical, regulatory),
- Technical documentation management (IEC 62304, ISO 14971)
- Market launch strategy.
- Obtaining ANS, SESAM vitale certification
- SateliaTechnical and Regulatory EngineerHEALTH AND WELLNESSOctober 2023 - February 2025 (1 year and 4 months)Bordeaux, France
- Support for regulatory compliance of medical devices, with a specialization in software (SaMD).
- Drafting and review of the technical file,
- Design file drafting: risk analysis, software validation, clinical evaluation, classification strategy, PMS
- Implementation of QMS and obtaining ISO 13485 certification.
- Key interface between technical teams and authorities
- Laureen ROSELIA PANCALDIQARA ManagerCONSULTING AND AUDITSSeptember 2023 - Today (2 years and 9 months)Toulouse, FranceSupport for companies during the design and development of medical device software according to MDR 2017/745 and standards IEC 62304 - 62366 - 82304.Risk management of medical devices - ISO 14971Implementation of Quality Management System and certification according to ISO 13485.
Recommendations
Be the first to recommend Laureen
Help this freelancer shine by sharing your experience working together.
These freelancer profiles also match your criteria
Agatha Frydrych
Backend Java Software Engineer
4.7
(3)
2
Baptiste Duhen
Fullstack developer
4.6
(4)
5
Amed Hamou
Senior Lead Developer
4
(2)
7
Audrey Champion
Web developer
4.3
(3)
4
Education
- Master in Engineering, EEA - Medical Radiophysics and Biomedical EngineeringUniversité Paul Sabatier Toulouse III2021Master en ingénierie, EEA - Radiophysique Médicale et Génie Biomédical
Certifications
- ISO 13485:2016BSI2023
Skill set (21)
Categories
- Other