FSCA.com, Vigilance in Life Sciences

Hospital & Health Care - The Hague, South Holland, Netherlands

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A manufacturer of life science products such as medical devices should establish a comprehensive post-market surveillance and vigilance system. Part of that can be the publication of Field Safety Notices. In a secured environment, FSCA.com facilitates the manufacturer in the follow-up of corrective actions after such a Safety Notice. Healthcare institutions can provide the requested data at no cost via this same secured environment and receive a written confirmation of the provided data.Een fabrikant van producten voor de zorg, zoals medische hulpmiddelen, moet beschikken over een uitgebreid systeem van toezicht na het in de handel brengen van het product. Onderdeel daarvan kan zijn het publiceren van een veiligheidswaarschuwing, ook wel genoemd een "recall". In een beveiligde omgeving faciliteert FSCA.com de fabrikant bij de publicatie en de opvolging van corrigerende acties na een veiligheidswaarschuwing. Zorginstellingen kunnen via deze zelfde beveiligde omgeving kosteloos de gevraagde data aanleveren en krijgen daarvan een schriftelijke bevestiging.

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Employees: 1
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Location: The Hague, South Holland, Netherlands
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