Freelancer profile translated to English.
Back to original languageAbout Amandine
Expert in Usability Engineering (Human Factors) applied to medical devices, I have been supporting manufacturers for over 10 years in securing their regulatory dossiers for CE marking and FDA submissions.
Throughout my career, I have assisted over 30 medical device and health software manufacturers in implementing the usability engineering process in accordance with regulatory requirements (EN 62366-1, IEC 60601-1-6, FDA Human Factors Guidance).
I am involved in all activities related to human factors and usability engineering, including:
- Definition of usability strategy and integration into design control
- Use error analysis (ISO 14971)
- Use specification and identification of critical tasks
- Design and conduct of formative evaluations
- Writing of summative evaluation protocols (CE / FDA)
- Organization and conduct of user testing
- Results analysis and root cause analysis
- Writing of evaluation reports for regulatory dossiers
I also support teams in structuring their entire dossier to ensure consistency between design control, risk management, and demonstration of safe use.
My missions also cover support in preparing market authorization applications, with a constant objective: to secure regulatory compliance while facilitating device development.
French
Native or bilingual
English
Fluent
Can work on-site
Lille (up to 50km), Paris (up to 50km), Lyon (up to 50km), Toulouse (up to 50km)
Experience
- UsareaCo-Manager, Usability Engineering SpecialistMEDICALSeptember 2024 - Today (1 year and 9 months)
- Application of the usability engineering process to medical devices and IVDs (risk analysis in conjunction with ISO 14971, specifications, formative and summative evaluations, protocols, reports, usability engineering report, impact analyses) for CE marking and FDA approval.
- Planning of usability engineering strategies.
- Training and support in the implementation of the IEC 62366 standard for usability engineering in medical devices.
- Conducting studies for drug market authorizations.
- Business management
- Broussier Amandine (Auto-entreprise)Manager, Usability Engineering SpecialistMEDICALOctober 2023 - September 2024 (11 months)Lille, France
- Application of the usability engineering process to medical devices classes I to III and IVDs (risk analysis, specifications, formative and summative evaluations, protocols, reports, usability engineering report) for CE marking and FDA approval.
- Planning of usability engineering strategies.
- Training and support in the implementation of the IEC 62366 standard for usability engineering in medical devices.
- Business management.
- UseConceptProject Manager, Usability Engineering SpecialistMEDICALNovember 2016 - July 2023 (6 years and 8 months)
- Application of the usability engineering process to medical devices classes I to III and IVDs (risk analysis, specifications, formative and summative evaluations, protocols, reports, usability engineering report) and conducting studies for drug market authorizations.
- Project management
Recommendations
Be the first to recommend Amandine
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 en sciences cognitives appliquées à l'entrepriseUniversité Lille 32017Master en sciences cognitives appliquées à l'entreprise
- Licence en Mathématiques, Informatique et sciences cognitivesUniversité Lille 32015Licence en Mathématiques, Informatique et sciences cognitives
Skill set
Categories
- Other