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Aisling O’Sullivan

Aisling is responsible for ensuring that all the quality and regulatory requirements which are applicable to the OrthoXel products and systems, are implemented and communicated throughout the organisation.  She determines regulatory strategies for successful approval of the OrthoXel products, leads the OrthoXel team in meeting these requirements and engages with the relevant regulatory authorities to obtain approval.

Aisling has a considerable amount of experience in design dossier review and preparation and managing on-site Quality Management System audits of drug device combination products, implantable devices, products incorporating human blood derivatives and tissue of animal origin as well as in-vitro diagnostic devices, following her years working with the Irish Notified Body, the NSAI, as well as various medical device start-up companies