Ayelen Culó Montórfano
Senior Consultant and Auditor in Medical Devices @Quara Consulting & Training
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WORK HISTORY
Senior Consultant and Auditor in Medical Devices @Quara Consulting & Training
US
Drafting technical specifications and inspection protocols for UNFPA (United Nations Population Fund) international medical devices tenders, ensuring compliance with WHO PQ, EU MDR & FDA quality requirements- Coordination and assessment medical device bids, including technical specifications and regulatory requirements- Preparetion technical files and dossiers for the registrations of medical devices across LATAM markets FDA and CE- Consulting for the maintenance and improvement of the QMS according to ISO 13485.
EDUCATION
Universidad Nacional de Entre Ríos
Bioengineer
TÜV Rheinland
IRCA ISO 9001:2008 Auditor/Lead Auditor
Universidad ISALUD
Diploma in Design and Management of Infrastructure and Technology in Health
ABOUT AYELEN CULÓ MONTÓRFANO
Biomedical engineer with 15+ years driving regulatory affairs and project management for…
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