Freelancer profile translated to English.

Description

I support medical software publishers towards compliance (IEC 62304, CE marking, cybersecurity), combining regulatory expertise and technical intervention.

I offer two types of services:

1. Support for existing software towards compliance

Supervision and support for documentation production (Software Development Plan, Architecture, Risk Management, Cybersecurity, etc.).
Technical audit: identification of deviations from standards (IEC 62304, IEC 81001-5-1, MDR, FDA Guidance, etc.).
Concrete implementation of missing practices: code refactoring, security hardening (authentication, encryption, access control), integration of testing frameworks, introduction of minimal CI/CD, etc.
Work that is bothstrategicand **operational**: I can produce/review documentation, but also modify code to align the product with regulatory requirements.

2. Development of compliant-by-design prototypes and architectures

Design and development of application prototypes (backend, API, lightweight frontend if needed).
Implementation of a modular and testable software architecture, integrating from the start: Strong typing, Adapted testing frameworks (unit, integration, security), Minimalist CI/CD, Configuration and versioning practices compliant with standards.
The objective: **accelerate regulatory compliance from the first versions**, and avoid costly refactoring during the CE marking process.

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Marseille (up to 10km)

Glad Medical
Software Architecture Consultant
MEDICAL
November 2024 - Today (1 year and 7 months)
Marseille, France
Medical Device Compliance & CE Marking

Led the redesign of software architecture and code refactoring for a medical device software for CE marking (EU MDR).
Architected and completely refactored the existing codebase with a focus on security, maintainability, and compliance according to IEC 62304.
Contributed to technical documentation and risk management (ISO 14971, cybersecurity requirements).
Implemented CI/CD pipelines and supported teams on secure coding and regulatory practices.
Software Architecture IEC 62304 ISO 14971 Python Keycloak
Université Gustave Eiffel
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Collaboration with doctors and researchers to define relevant medical thresholds and event logic.
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Project monitoring and communication with technical and non-technical stakeholders.
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