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GALLANT Victor
Compétences
GALLANT Victor

Victor is a doctor of pharmacy who has been specialised in medical devices Development and validation.

Through a broad experience in multiple projects, Victor has gained years of expertise in quality assurance and regulatory affairs from class I to III devices.

Area of expertise :

Set up of QMS as per ISO 13485:2016 and 21CFR820.

Support for CE certification and FDA clearance.

Certified internal auditor.

Notification to national competent authorities.

MDR 2017/745

Medical Devices Lifecycle Management.

Interface with the notified body.

Technical documentation management.

Change control, CAPA, deviation/non conformity.

Regulatory intelligence.

Stérilisations (irradiation, heat, filtration).

Sealing.

Software validation.

Societe
COVARTIM