Freelancer profile translated to English.
Back to original languageAbout Stéphanie
Is your MDR compliance documentation sufficient and receivable? What do inspectors expect and what are their methods? And AI in all this? And PPWR?
Experienced Quality Auditor and evaluator (ANSM, ON), I can help you optimally document your compliance evidence, prioritize decisions, and secure your exchange timelines with authorities, organizations, and clients.
My service offering per deliverable/time:
- One or more discussion meetings without document sharing
- A review of the complete documentation: consistency, structure, completeness.
- A more technical analysis in case of a targeted question
- Updated regulatory monitoring + MDR 2.0 + Eudamed + HAS
- Review of responses to non-conformities
Written restitution in the desired format (table, annotations, comments in each document...) + oral summary.
Duration: min 1 day + if necessary.
Other services - scope to be adapted
- Support in the digital transformation of your organization: mapping your operational flows in regulatory and quality, workflow requested by
- Use cases in Freelance of Claude Cowork in document generation and compliance review: what can be done without an agency, IT infrastructure, or software.
- Mock audit, internal process audit
- Dedicated Medical Device Vigilance training adapted to your context
Frequently encountered cases:
How to choose an AI SaaS for our QMS or clinical literature review?
We don't understand what the evaluator expects; we provided the answer in the previous file.
Should additional tests be carried out, or can we rely on existing evidence?
What actions to take following a standard revision?
How to demonstrate the acceptability of the benefit-risk ratio?
A doubt about understanding a non-conformity?
English
Native or bilingual
French
Native or bilingual
German
Basic
Chinese
Basic
Can work on-site
Paris (up to 10km), Saint-Brieuc (up to 10km)
Experience
- Association 3APS- Auditeurs des Produits de SantéPresident of the associationCIVIC AND SOCIAL ORGANIZATIONSSeptember 2024 - Today (1 year and 9 months)Bourg-la-Reine, FranceCommitted to the professional association that has been offering its 50 Health Auditor members since 2012: peer training, workshops, monitoring, and documentary resources. This allows us to ensure the maintenance of our skills and to prove it to our clients and health authorities. And today, to collectively reinvent our compliance professions and methods.A true association management software has been operational since January 2025. Fewer useless volunteer tasks, centralized information for everyone >> connection and a new collective momentum for the next board :)
- Dekra CertificationISO Audit ManagerCONSULTING AND AUDITSMay 2024 - Today (2 years and 1 month)Le Plessis-Robinson, FranceISO 9001, ISO 22716, ISO 20252, HAS Audit ManagerAudit planning, audit schedule, audit conduction, audit report.Good mastery of audit techniques, professions, stakeholders, and certification stakes for all actors.
- Spécialiste Certification Réglementaire et Normative en SantéFounder and Service ProviderCONSULTING AND AUDITSApril 2024 - Today (2 years and 2 months)Bourg-la-Reine, France• - MDR evaluations and quality audits for notified bodies and certification bodies• - Occasional support for manufacturers: regulatory diagnosis, MDR transition, action plans, internal audits, non-conformity management, mentoring
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Education
- Master 2 Public Health and Environmental Risks2017Master 2 Santé Publique et risques environnementaux
- Doctorate and Residency (DES) in PharmacyUniversité Paris V2010Doctorat et DES en Pharmacie
Certifications
- CSR & Digital MarketingLiveMentor2026