Fabiènne Péters

I am a senior consultant in medical device, providing consulting services for QMS (ISO13485/ CFR820), product files and regulatory submissions.

I have over 15 years’ experience in the medical device industry. This includes 12 years at an airway management company, working as Head QAC/RA Officer, Supply chain Manager, Project Manager and Sr. Project Developer and 5 years working in a tissue engineering company (under GLP/GMP) as Sr. R&D technician and QC supervisor.

Prior to working in the medical device industry, I started my professional career in a Chemical company as an Analytical R&D technician, and later as a Polymer Researcher in a Food & Biobased company.

I can fulfill various functions like e.g. QA/RA manager, Project manager/Expert member in D&D, Production and Supply chain projects, QC manager and Auditor.

My fields of expertise are in :

Set-up quality management systems (ISO13485/21CFR820)

Set-up/write/maintain design history files, technical dossiers, 510(k) dossiers and master files

Project management design & development of medical devices

Analytical chemistry / Polymer chemistry

Equipment qualifications and validations (e.g. production, packaging, shelf-life)

Manufacturing and sterilization methods (e.g. injection molding, 3D printing, extrusion, gamma/eto sterilization)

Improvement processes in production and quality control

Internal auditing and/or supplier auditing

Communication with test laboratories (chemical, mechanical and biological tests) or  with notified bodies/authorities

Hands on support, coaching and training

Biological safety evaluation of medical devices

 

A detailed curriculum vitae will be provided upon request